AMPLATZER™ 9-AVP2-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00811806010373), received between Oct 9, 2018 and Aug 22, 2025 — classified as 24 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Difficult to Fold, Unfold or Collapse; Separation Problem; Difficult to Fold, Unfold or Collapse; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, TWO 8MM AMPLATZER VASCULAR PLUG II DEVICES WERE SELECTED FOR THE PDA PROCEDURE AND PREPARED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU). EACH DEVICE WAS INSPECTED DURING THE PREPARATION TO THE PROCEDURE, AND NO ABNORMALITIES OBSERVED. HOWEVER, DURING THE PROCEDURE, BOTH DEVICES COULD NOT BE UNSCREWED AS EXPECTED. NO HOLES WERE OBSERVED IN THE MESH PRIOR TO INSERTION INTO THE PATIENT ANATOMY. UPON REMOVAL, ONE DEVICE (8MM AMPLATZER VASCULAR PLUG II LOT # 10281568) WAS FOUND TO HAVE A HOLE IN THE CENTER OF ITS BODY. NEITHER OF THE COMPLAINT DEVICES WAS IMPLANTED. THERE WERE NO DIFFERENCES IN HOW THE TWO DEVICES WERE HANDLED OR USED PRIOR TO THEIR RETURN TO THE MANUFACTURER. THE PATIENT EXHIBITED NO CLINICAL SIGNS OR SYMPTOMS DURING OR AFTER THE EVENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877841 ↗
• MalfunctionApr 28, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE PROCEDURE. DURING PROCEDURE, WHEN THE PHYSICIAN REMOVED THE DEVICE VIA DELIVERY SHEATH AFTER TRYING TO POSITION IT IN THE PDA, REMOVED THE CABLE FROM THE SHEATH THE DEVICE 'FELL' OFF THE END OF THE CABLE. THE PHYSICIAN DECIDED RE-SCREW IT BACK AND REINTRODUCED INTO THE PDA. BUT THE DEVICE WAS TOO SMALL TO OCCLUDE THE PDA AND A NEW 10MM AMPLATZER VASCULAR PLUG II WAS CHOSEN AND COMPLETED THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS REPORTED DISCHARGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21920055 ↗
• MalfunctionOct 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024, A 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR A PERCUTANEOUS CLOSURE PROCEDURE OF THE ARTERIAL DUCT. DURING PROCEDURE, A SMALL HOLE IN THE MESH OF THE CENTRAL DISC WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439596 ↗
• InjuryOct 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8MM AMPLATZER VASCULAR PLUG II WAS IMPLANTED DURING A VENTRICULAR SEPTAL DEFECT SURGERY. ON A LATER DATE, IT WAS NOTED THAT THE ORIGINALLY BLOCKED SURGICAL SITE WAS FOUND TO HAVE BLOOD LEAKAGE FROM THE BRANCH OF THE BLOOD VESSEL. ON (B)(6) 2024, A 6MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. DURING THE PROCEDURE, THE DEVICE WAS NOT ABLE TO BE ADVANCED. ON ANGIOGRAPHY, IT APPEARED THAT THE VESSEL PATH WAS TOO NARROW AND CURVED, MAKING IT IMPOSSIBLE TO REACH THE TARGET LOCATION FOR PLACEMENT OF THE DEVICE. THE DEVICE WAS REMOVED. PATIENT WAS SENT TO SURGERY TO CONTROL THE BLEEDING FROM THE BLOOD VESSEL AND NOT DUE TO A DEVICE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20346155 ↗
• InjurySep 20, 2024Off-Label Use; Off-Label Use

  CLINICAL INFORMATION: CRD_967 - PARADIGM, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2024, A 8X4 MM AMPLATZER VALVULAR PLUG III WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, THE DEVICE INTERACTED WITH THE MECHANICAL DISK OF AN UNKNOWN AORTIC MECHANICAL VALVE. THE DECISION WAS MADE TO PERCUTANEOUSLY EXPLANT THE 8X4 MM AMPLATZER VALVULAR PLUG 3. AN 8MM AMPLATZER VASCULAR PLUG 2 WAS PREPARED FOR PROCEDURE AND RELEASED FROM THE DELIVERY CABLE. HOWEVER, THE DECISION WAS MADE TO ALSO PERCUTANEOUSLY EXPLANT THE 8MM AMPLATZER VASCULAR PLUG 2 DUE TO AN UNKNOWN REASON.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 20271049 ↗
• InjuryJul 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 8MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT ON (B)(6) 2024. DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE WAS FAULTY. THE DEVICE WAS REMOVED FROM THE PATIENT AND RINSED IN SALINE. IT WAS NOTED THAT THERE WAS A HOLE IN THE NITINOL MESH. THE DEVICE WAS REPLACED WITH A NEW 10MM AMPLATZER VASCULAR PLUG II. THE PATIENT WAS HOSPITALIZED FOR TREATMENT OF A CHEST INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19841249 ↗
• MalfunctionApr 18, 2024Off-Label Use; Material Deformation; Off-Label Use; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 8MM AMPLATZER VASCULAR PLUG II (AVPII) LOT: 8715833 WAS CHOSEN FOR IMPLANTATION TO TREAT A PERIVALVULAR LEAK UTILIZING A NON-ABBOTT DELIVERY SYSTEM. THE DEVICE WAS PREPARED WITHOUT ISSUE. WHEN PLACING THE DEVICE, CONTRAST AGENT WAS FLOWING OUT SO THE DEVICE WAS REMOVED FROM THE PATIENT. OUTSIDE OF THE PATIENT A LARGE HOLE WAS OBSERVED IN THE DEVICE ON THE EDGE OF THE MIDDLE LOBE OF NITINOL MESH. A REPLACEMENT 8MM AVPII WAS USED TO COMPLETE THE PROCEDURE WITH THE SAME DELIVERY SYSTEM. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130303 ↗
• InjuryDec 6, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 2 MONTH OLD PATIENT WEIGHING 3.5 KG THAT WAS BORN PRE-TERM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 5 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE AND REPLACE WITH A 6-4MM NON-ABBOTT CONVENTIONAL DUCT OCCLUDER. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER VASCULAR PLUGS ARE OFTEN ASSOCIATED WITH EMBOLISATIONS. INTENTIONAL DEVICE UNDERSIZING TO AVOID VASCULAR OBSTRUCTION IN SMALL PATIENTS IS A FREQUENT RISK FACTOR FOR EMBOLISATION. PRECISE ECHOCARDIOGRAPHIC MEASUREMENTS, CORRECT OCCLUDER C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278981 ↗
• InjuryDec 6, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 2 MONTH OLD PATIENT WEIGHING 3.5 KG. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 5 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE AND REPLACE WITH A 5-7MM NON-ABBOTT CONVENTIONAL DUCT OCCLUDER. AFTER INTERVENTION PROCEDURE, IT WAS REPORTED THE PATIENT DEVELOPED LEFT PULMONARY STENOSIS. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER VASCULAR PLUGS ARE OFTEN ASSOCIATED WITH EMBOLISATIONS. INTENTIONAL DEVICE UNDERSIZING TO AVOID VASCULAR OBSTRUCTION IN SMALL PATIENTS IS A FREQUENT RISK FACTOR FOR EM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278684 ↗
• InjuryDec 6, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED.THE ARTICLE PRESENTED A CASE STUDY OF A 2 MONTH OLD PATIENT WEIGHING 3.7 KG. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 6 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE AND REPLACE WITH AN 10MM AMPLATZER VASCULAR PLUG II. DURING THE IMPLANT PROCEDURE WITH THE 10MM AMPLATZER VASCULAR PLUG II, IT WAS NOTED THE DEVICE LED TO AORTIC PROTRUSION AND A DECISION WAS MADE TO REMOVE THE DEVICE. IT IS UNKNOWN IF THE SECOND DEVICE WAS RELEASED FROM THE DELIVERY CABLE PRIOR TO REMOVAL FROM THE PATIENT. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278642 ↗
• InjuryDec 5, 2023Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 1 MONTH OLD PATIENT WEIGHING 2.1 KG THAT WAS BORN PRE-TERM. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 6MM AMPLATZER VASCULAR PLUG IV WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 4 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE AND REPLACE WITH AN 8MM AMPLATZER VASCULAR PLUG II. AFTER INTERVENTION PROCEDURE, IT WAS REPORTED THE PATIENT DEVELOPED LEFT PULMONARY STENOSIS. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER VASCULAR PLUGS ARE OFTEN ASSOCIATED WITH EMBOLISATIONS. INTENTIONAL DEVICE UNDERSIZING TO AVOID VASCULAR OBSTRUCTION IN SMALL PATIENTS IS A FREQUENT RISK FAC

  Patient problems: Obstruction/Occlusion

  MAUDE report 18269094 ↗
• InjuryDec 5, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 2 MONTH OLD PATIENT WEIGHING 3.2 KG. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 6 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE AND REPLACE WITH A 10MM AMPLATZER VASCULAR PLUG II AND AN 8-6MM NON-ABBOTT CONVENTIONAL DUCT OCCLUDER. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER VASCULAR PLUGS ARE OFTEN ASSOCIATED WITH EMBOLISATIONS. INTENTIONAL DEVICE UNDERSIZING TO AVOID VASCULAR OBSTRUCTION IN SMALL PATIENTS IS A FREQUENT RISK FACTOR FOR EMBOLISATION. PRECISE ECHOCARDIOGRAPHIC MEASUREMENTS, CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268484 ↗
• InjuryDec 5, 2023Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THE ARTICLE, ¿RISK FACTORS ASSOCIATED WITH DEVICE EMBOLISATION OR MALPOSITION DURING TRANSCATHETER CLOSURE OF PATENT DUCTUS ARTERIOSUS¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 4 MONTH OLD PATIENT WEIGHING 3.9 KG WITH COMORBIDITIES SEPSIS, SEIZURES, AND EFFUSION. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO TREAT PATENT DUCTUS ARTERIOSUS (PDA) THAT WAS SIZED 5 MM. IT WAS THEN REPORTED ON AN UNKNOWN DATE, THE DEVICE HAD EMBOLIZED AND A DECISION WAS MADE TO RETRIEVE THE DEVICE VIA TRANSCATHETER SNARE. IT WAS THEN REPORTED THAT TRIALS WITH 8 MM AMPLATZER VASCULAR PLUG AND BIOPTOME-ASSISTED MULTIPLE COILS TO CLOSE THE PDA WAS UNSUCCESSFUL. THE PATIENT UNDERWENT UNEVENTFUL SURGERY FOR THE PDA CLOSURE. THE ARTICLE CONCLUDED DEVICE EMBOLISATION COMPLICATES 4% OF TRANSCATHETER DUCT CLOSURES, WITH NEED FOR SURGERY IN ONE-FIFTH OF THEM. LARGER DUCTS WITH HIGH PULMONARY ARTERY PRESSURES IN YOUNGER AND SMALLER INFANTS ARE MORE OFTEN ASSOCIATED WITH DEVICE EMBOLISATION. TUBULAR DUCTS ARE MORE PRONE FOR EMBOLISATION COMPARED TO USUAL CONICAL DUCTS. SOFTER VASCULAR PLUGS ARE OFTEN ASSOCIATED WITH EMBOLISATIONS. INTENTIONAL DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267860 ↗
• MalfunctionSep 27, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 8MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR AN IMPLANT. THE PROCEDURE WAS TO TREAT AN PATENT DUCTUS ARTERY LESION. AT THE BEGINNING OF THE OPERATION, 5F DELIVERY CATHETER (UNKNOWN) WAS IN PLACED. THE PLUG WAS IMPLANTED, AND THE LEAK WAS OBSERVED 3 MINUTES LATER. THE CONTRAST AGENT STILL PASSES THROUGH THE TARGET VESSEL DUE TO POOR ADHERENCE. SO THE PHYSICIAN REPLACED WITH A NON-ABBOTT DEVICE TO COMPLETE THE PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826184 ↗
• InjurySep 8, 2023Off-Label Use; Off-Label Use

  CLINICAL INFORMATION: (B)(6), PATIENT SITE ID:(B)(6). IT WAS REPORTED THAT ON (B)(6) 2023, A 10 MM X 5 MM AMPLATZER VALVULAR PLUG 3 WAS SELECTED FOR PROCEDURE IN ATTEMPT TO OCCLUDE A MODERATE PERIVALVULAR LEAK/MILD AORTIC REGURGITATION OF A NON-ABBOTT DEVICE. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA FOR PROCEDURE. THE 10 MM X 5 MM AMPLATZER VALVULAR PLUG 3 WAS ADVANCED THROUGH THE DELIVERY SHEATH, ORIENTED IN THE LEFT VENTRICLE CAVITY, AND DEPLOYED WITHIN THE PERIVALVULAR LEAK. MULTIPLE ATTEMPTS WERE MADE WITH MOSTLY GOOD ORIENTATION, BUT THE REGURGITATION/LEAK WAS LITTLE CHANGED AND THE PROXIMAL DISC WAS SEEN TO INTERFERE WITH THE NON-ABBOTT AORTIC VALVE LEAFLET. DESPITE MULTIPLE ATTEMPTS WITH THE PLUG IN DIFFERENT POSITIONS, A SATISFACTORY POSITION COULD NOT BE ACHIEVED. THE 10 MM X 5 MM AMPLATZER VALVULAR PLUG 3 WAS REMOVED AND A 12MM X 5MM AMPLATZER VALVULAR PLUG 3 WAS SIMILARLY POSITIONED AND AGAIN, DESPITE MULTIPLE ATTEMPTS, REGURGITATION COULD NOT BE EXTINGUISHED AND THE PROXIMAL DISC AGAIN INTERFERED WITH THE NON-ABBOTT AORTIC VALVE LEAFLET. THE 12MM X 5MM AMPLATZER VALVULAR PLUG 3 WAS REMOVED, AND SEVERAL ATTEMPTS WERE MADE TO POSITION TWO 8 MM AMPLATZER VASCULAR PL

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Hemolytic Anemia; Low Blood Pressure/ Hypotension

  MAUDE report 17713027 ↗
• InjuryAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ARTICLE, ¿A CHALLENGING INTERVENTIONAL PROCEDURE: TRANSCATHETER CLOSURE OF TUBULAR PATENT DUCTUS ARTERIOSUS IN PATIENTS WITH PULMONARY HYPERTENSION¿, WAS REVIEWED. THE ARTICLE PRESENTS A CASE STUDY OF AN 5-MONTH-OLD, 5KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 5.2MM, AMPULLA DIAMETER = 7.7MM, DUCTAL LENGTH = 6.9MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER THE DEVICE WAS IMPLANTED, IT WAS NOTED THERE WAS A RESIDUAL SHUNT. A DECISION WAS MADE TO ADDITIONALLY IMPLANT A 10MM AMPLATZER VASCULAR PLUG II. THE SECOND DEVICE WAS IMPLANTED SUCCESSFULLY. [THE PRIMARY AND CORRESPONDING AUTHOR IS ILKER KEMAL YUCEL, DEPARTMENT OF PEDIATRIC CARDIOLOGY, UNIVERSITY OF HEALTH SCIENCES DR. SIYAMI ERSEK THORACIC AND CARDIOVASCULAR SURGERY TRAINING AND RESEARCH HOSPITAL, ISTANBUL, TURKEY, [email protected]] PERIPROCEDURAL COMPLICATIONS INCLUDED RESIDUAL SHUNT AND SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541600 ↗
• InjuryApr 7, 2023Off-Label Use; Off-Label Use

  THE ARTICLE "EARLY SPONTANEOUS CLOSURE OF LARGE ARTERIAL DUCTS IN TWO TERM NEONATES WITH EBSTEIN ANOMALY AFTER FAILED ATTEMPTS OF TRANSCATHETER CLOSURE" WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 9 DAY OLD FEMALE PATIENT WITH WITH EBSTEIN¿S ANOMALY OF THE TRICUSPID VALVE AND A SIGNIFICANT ARTERIAL DUCT. THE PULMONARY END OF THE ARTERIAL DUCT WAS 6.3MM, AND THE LENGTH WAS 8.9MM. AN 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN TO CLOSE THE ARTERIAL DUCT USING A 5F JR 3.0 LAUNCHER CORONARY GUIDE CATHETER (MANUFACTURER: MEDTRONIC). A RESIDUAL SHUNT WAS OBSERVED AND THE DEVICE WAS NOT STABLE IN THE DEFECT, SO THE DEVICE WAS REMOVED PRIOR TO RELEASE FROM THE DELIVERY CABLE. THE CATHETER WAS EXCHANGED TO 6F, DURING WHICH THE PATIENT EXPERIENCED TWO EPISODES OF VENTRICULAR TACHYCARDIA. A CARDIOVERSION WAS REQUIRED. A 10MM AMPLATZER VASCULAR PLUG II WAS THEN ATTEMPTED FOR IMPLANT, BUT THE DELIVERY WAS LABORIOUS. THE PROCEDURE WAS ABORTED DUE TO ACCESS-RELATED BLEEDING NOTED. TWO DAYS FOLLOWING THE PROCEDURE, THERE WAS A SPONTANEOUS COMPLETE DUCTAL CLOSURE, AND THE PATIENT HAD A GOOD FINAL CLINICAL OUTCOME. THE PRIMARY AUTHOR OF THE ARTICLE IS RAYMOND N. HADDAD, HÔPITAL UNIVE

  Patient problems: Tachycardia

  MAUDE report 16704485 ↗
• MalfunctionApr 6, 2023Difficult to Fold, Unfold or Collapse; Fracture; Difficult to Fold, Unfold or Collapse; Fracture

  IT WAS REPORTED THAT ON 13 MARCH 2023, AN 8MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. THE GOAL OF THE PROCEDURE WAS PERSISTENT DUCTUS ARTERIOSUS OCCLUSION. THE DEVICE WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND WASHED WITH SALINE SOLUTION. WHILE ATTEMPTING TO POSITION THE PLUG, IT WAS RETRACTED AND REDEPLOYED THREE TIMES DUE TO THE INSTABILITY OF THE CENTRAL DISC, WHICH CAUSED DIFFICULTY POSITIONING THE DEVICE. THE DEVICE REMAINED ATTACHED TO THE DELIVERY CABLE AND WAS REMOVED FROM THE PATIENT. AFTER REMOVAL, IT WAS OBSERVED THAT THERE WAS A HOLE THROUGH THE NITINOL MESH IN THE CENTRAL DISC OF THE DEVICE. A 10MM AMPLATZER VASCULAR PLUG II WAS THEN CHOSEN FOR IMPLANT TO REPLACE THE 8MM DEVICE. THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED, AND THE PROCEDURE WAS CONCLUDED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED THAT THE DEVICE WAS CHECKED PRIOR TO IMPLANT. WHEN ATTEMPTING TO IMPLANT THE DEVICE, THE CENTRAL DISC WAS NOT TAKING THE CORREC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16691804 ↗
• MalfunctionOct 3, 2022Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2022, A 8MM AMPLATZER VASCULAR PLUG 2 (AVP2) WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. IT WAS NOTED DURING PROCEDURE THAT THE PLUG EXHIBITED AN UMBRELLA SHAPED DEFORMATION WHEN BEING DEPLOYED. THE DEFORMED 8MM AMPLATZER VASCULAR PLUG WAS NEVER RELEASED FROM THE DELIVERY CABLE WHILE INSIDE THE PATIENT. THERE WAS NO NOTED INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT. THE DECISION WAS MADE TO REMOVE THE 8MM AMPLATZER VASCULAR PLUG 2 AND REPLACE IT WITH ANOTHER ONE OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THE PLUGS HAD BEEN SIZED USING FLUOROSCOPIC AND ECHOCARDIOGRAPHIC EXAMINATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15532566 ↗
• InjuryJun 8, 2022Migration or Expulsion of Device; Off-Label Use; Patient Device Interaction Problem; Migration or Expulsion of Device; Off-Label Use; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER VASCULAR PLUG II WAS SUCCESSFULLY IMPLANTED TO REPAIR A PATENT DUCTUS ARTERIOSUS (PDA) USING A 5F AMPLATZER TORQVUE LP DELIVERY SYSTEM. THE DEVICE WAS WELL PLACED, THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT WAS STABLE. THERE WAS NO DIFFICULTY IMPLANTING THE DEVICE. ON (B)(6) 2022, A FOLLOW-UP ULTRASOUND AS PERFORMED, AND THERE WAS EVIDENCE OF DISPLACEMENT OF THE DEVICE AND LEAKAGE. THERE WERE NO REPORTS OF ANY SUDDEN MOVEMENT OR FALL THAT MAY HAVE ACCOUNTED FOR THIS EVENT. THE DEVICE WAS THEN RETRIEVED USING A TRANSCATHETER SNARE. A REPLACEMENT DEVICE, A 10MM AMPLATZER VASCULAR PLUG II, WAS THEN SUCCESSFULLY IMPLANTED TO RESOLVE THIS EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT HAS SINCE BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14636563 ↗
• InjuryDec 22, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A 8MM AMPLATZER VASCULAR PUG 2 WAS SELECTED FOR AN IMPLANT ON (B)(6) 2021. DEVICE DISLODGED COMPLETELY AND IMMEDIATELY WITH DEPLOYMENT AND EMBOLIZED INTO THE PATIENT¿S LEFT EXTERNAL ILIAC ARTERY. THE EMBOLIZED DEVICE DID NOT CAUSE A BLOCKAGE OF CAROTID ARTERY STENTING (CAS). DEVICE WAS SIZED BY ECHOCARDIOGRAM AND FLUOROSCOPY. THE IMPLANTER BELIEVE EMBOLIZATION WAS CAUSED BY A RIDGE OF CALCIUM THAT CAUSED THE DEVICE TO SHIFT OUT OF ITS DEPLOYED POSITION. THE LEFT COMMON FEMORAL ARTERY WAS ACCESS WITH A SHORT SIX FRENCH TERUMO PINNACLE SHEATH (6F X 10CM), 10MM ENSNARE TO RETRIEVE THE DEVICE. THE PATIENT WAS NOT HEMODYNAMICALLY STABLE PRIOR TO PROCEDURE AND PRIOR TO EMBOLIZATION NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13064343 ↗
• InjurySep 22, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  USER FACILITY MEDWATCH RECEIVED THAT STATES THAT ON (B)(6) 2021, A 8 MM AMPLATZER VASCULAR PLUG II WAS SUCCESSFULLY IMPLANTED IN A PATIENTS PATENT DUCTUS ARTERIOSUS (PDA) WITH HIGH CARDIAC OUTPUT HEART FAILURE. POST-PROCEDURE, WHILE THE PATIENT WAS RECEIVING ECHOCARDIOGRAM. IT WAS NOTED THAT THE DEVICE HAD EMBOLIZED FROM THE PATENT DUCTUS ARTERIOSUS (PDA) TO THE LEFT PULMONARY ARTERY (LPA). THE PATIENT WAS BROUGHT BACK TO CARDIAC CATH LAB, WHERE THE EMBOLIZED DEVICE WAS RETRIEVED, AND A 10MM ABBOTT VASCULAR PLUG 2 WAS IMPLANTED IN THE PDA. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Pulmonary Edema

  MAUDE report 12514428 ↗
• InjuryApr 21, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  ON (B)(6) 2021, A 8MM AMPLATZER VASCULAR PLUG II WAS IMPLANTED. DURING ROUTINE FOLLOW-UP TRANSTHORACIC ECHOCARDIOGRAM (TTE) AFTER IMPLANT PROCEDURE IT WAS NOTED THAT THE DEVICE WAS NO LONGER IN PLACED AND HAD EMBOLIZED IN THE RIGHT PULMONARY ARTERY (RPA). THE PATIENT WAS TAKEN TO THE CATH LAB WHERE THE DEVICE WAS RETRIEVED AND REMOVED. A NEW 8MM AMPLATZER DUCT OCCLUDER (ADO) WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND NO COMPLICATIONS WERE NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700201 ↗
• InjuryApr 15, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00142, 2135147-2021-00143. ON (B)(6) 2021, A 8X6 MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT IN A (B)(6) MONTH OLD CHILD WITH A SHORT AND WIDE PATENT DUCTUS ARTERIOSUS (PDA). DURING THE PROCEDURE, INTRODUCTION OF THE CATHETER INDUCED AN ARRHYTHMIA AND REQUIRED CARDIOVERSION TO RESOLVE. ONCE THE PATIENT RHYTHM WAS RETURNED TO NORMAL, THE DEVICE WAS IMPLANTED AND DETACHED FROM THE DELIVERY CABLE IN THE PDA. THE DEVICE THEN WAS FOUND TO HAVE EMBOLIZED INTO THE PATIENTS PULMONARY ARTERY. ANOTHER ATTEMPT WAS MADE WITH A 10X8 MM AMPLATZER DUCT OCCLUDER, BUT THIS DEVICE EMBOLIZED AS WELL. A THIRD ATTEMPT WAS MADE WITH AN 8 MM AMPLATZER VASCULAR PLUG II, BUT AGAIN THE DEVICE EMBOLIZED. ALL DEVICES WERE REMOVED AND THE PROCEDURE WAS ABORTED WITH NO DEVICE IMPLANTED. THE PATIENT IS STABLE WITH NO ADVERSE HEALTH CONSEQUENCES. THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE EVENT WAS DUE TO MIS-SIZING OF DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675743 ↗
• InjuryNov 20, 2020Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  ON (B)(6) 2020, PATENT DUCTUS ARTERIOSUS(PDA) CLOSURE WAS ATTEMPTED IN A PATIENT. A 6MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT USING A RCFW 4.0-45-45-RB-CHB SHEATH. DURING THE PROCEDURE THE PHYSICIAN FELT THAT THE DEVICE WAS NOT SIZED PROPERLY. THE DEVICE WAS EXCHANGED FOR A 8MM AMPLATZER VASCULAR PLUG II AND THE 8MM DEVICE WAS DELIVERED THROUGH THE SAME SHEATH AND THE PROCEDURE WAS CONCLUDED. AN IMMEDIATE POST-OPERATIVE ECHO, IMAGING INDICATED THAT THE 8MM PLUG BECAME DISLODGED DISTAL TO THE DUCT. THE DEVICE WAS SNARED AND COMPLETELY REMOVED FROM THE PATIENT AND ANOTHER 8MM AMPLATZER VASCULAR PLUG II WAS PLACED WITHOUT INCIDENT. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Embolism

  MAUDE report 10877431 ↗