AMPLATZER™ 9-AVP2-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00811806010380), received between Oct 10, 2019 and Dec 1, 2025 — classified as 1 death, 21 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (13 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryDec 1, 2025Migration or Expulsion of Device; Separation Problem; Migration or Expulsion of Device; Separation Problem

  IT WAS REPORTED ON (B)(6) 2025 A 10MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. ALL STEPS WERE PERFORMED PER INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE THE PLUG WAS PARTIALLY RE-CAPTURED THREE TIMES. THE PLUG WAS UNABLE TO RELEASE FROM THE DELIVERY CABLE. AFTER UNSCREWING THE PLUG, THE PLUG EMBOLIZED TO THE LEFT ATRIUM. THE PLUG WAS SURGICALLY REMOVED FROM THE PATIENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23681931 ↗
• MalfunctionOct 10, 2025Premature Separation; Premature Separation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23265814 ↗
• MalfunctionSep 15, 2025Mechanical Problem

  THE PLUG WAS DEPLOYED BUT WOULD NOT RELEASE IN THE BODY. MD ATTEMPTED TO GET IT TO RELEASE 3 TIMES. THEN MD REMOVED IT. IT RELEASED ON THE BACK TABLE.

  Patient problems: Insufficient Information

  MAUDE report 23050500 ↗
• InjuryJan 29, 2025Migration or Expulsion of Device; Off-Label Use; Use of Device Problem; Premature Separation; Migration or Expulsion of Device; Off-Label Use; Use of Device Problem; Premature Separation

  IT WAS REPORTED THAT A 10MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT ON (B)(6) 2025 TO TREAT A PARAVALVULAR LEAK USING AN UNKNOWN DELIVERY CATHETER. THE DEVICES WERE PREPARED PER IFU. DURING THE PROCEDURE THE CABLE CONNECTION WAS CHECKED AND THE DEVICE WAS DEPLOYED. THE POSITION WAS NOT SATISFACTORY TO THE USER. THE DECISION WAS MADE TO RE-DEPLOY THE PLUG, HOWEVER IT WAS OBSERVED THAT THE PLUG WAS UNABLE TO BE RETRACTED. THE USER YANKED ON THE WIRE CAUSING THE PLUG TO SIMULTANEOUSLY DISCONNECT FROM THE DELIVERY CABLE AND DISLODGE FROM THE IMPLANT SITE. THE PLUG EMBOLIZED TO THE RIGHT ILIAC ARTERY. THE PLUG WAS SURGICALLY REMOVED. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265435 ↗
• InjuryFeb 22, 2024Migration or Expulsion of Device; Improper or Incorrect Procedure or Method; Migration or Expulsion of Device; Improper or Incorrect Procedure or Method

  THE ARTICLE, "GROWING RENAL VEIN ANEURYSM TREATED BY ENDOVASCULAR REPAIR: A CASE REPORT AND LITERATURE REVIEW", WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 74-YEAR-OLD MALE PATIENT WITH CHRONIC ATRIAL FIBRILLATION, MODERATE MITRAL REGURGITATION, CEREBRAL INFARCTION, PRIOR FALL INCIDENTS THAT REQUIRED EMERGENCY VISIT, AND A RENAL VEIN ANEURYSM (RVA) THAT MEASURED 17.1MM IN (B)(6) 2015 AND 35.7MM IN (B)(6) 2019. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 10MM AMPLATZER VASCULAR PLUG (AVP) II WAS CHOSEN FOR IMPLANT TO OCCLUDE THE RENAL VEIN ANEURYSM. IT WAS ALSO REPORTED TWO 22MM AMPLATZER VASCULAR PLUG II'S WERE CONCOMITANTLY PLACED IN THE ANEURYSM SAC TO REDUCE THE EMPTY SPACE AND PROMOTE THROMBUS FORMATION IN THE ANEURYSM LUMEN. AFTER THE 10MM AVP II WAS RELEASED, AFTER A WHILE, THE DEVICE DISLODGED INTO THE ANEURYSM. THE DEVICE WAS NOT RECAPTURED OR EXPLANTED. A DECISION WAS MADE TO IMPLANT A 16MM AMPLATZER VASCULAR PLUG II INTO THE NECK OF THE ANEURYSM. THE FINAL ANGIOGRAM DEMONSTRATED COMPLETE DISAPPEARANCE OF FLOW INTO THE ANEURYSMAL SAC. THE ANEURYSM SHRANK AND WAS COMPLETELY RESOLVED BY 12 MONTHS AFTER ENDOVASCULAR TREATMENT. THE ARTICLE CONCLUDED THAT THE AUTHORS S

  Patient problems: Foreign Body In Patient

  MAUDE report 18758363 ↗
• InjuryFeb 6, 2024Migration or Expulsion of Device; Detachment of Device or Device Component; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2024, A 10MM AND 16MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT.THE DIMENSION OF THE DEFECT MEASURED -8MM X 6MM AND WAS DONE BY ECHO, CT FUSION, AND FLUORO. DURING THE PROCEDURE, THE 10MM AMPLATZER VASCULAR PLUG II DEVICE BECAME DETACHED AFTER THE SHEATH WAS REMOVED AND EMBOLIZED IN THE LEFT VENTRICLE. THE PHYSICIAN TRIED TO IMPLANT A 16MM AMPLATZER VASCULAR PLUG II BUT ALSO EMBOLIZED IN THE LEFT VENTRICLE. THE DEVICES WERE BOTH SNARED NOTHING REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 16MM AMPLATZER VASCULAR PLUG II. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18655806 ↗
• MalfunctionDec 12, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, AN AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT INTO AORTIC PARAVALVULAR LEAK (PVL) IN THE NON-CORONARY CUSP. IT WAS INDICATED THAT THERE WAS A PRE-EXISTING 23MM NON-ABBOTT AORTIC VALVE IMPLANTED. A 12MM AMPLATZER VASCULAR PLUG II WAS ADVANCED THROUGH 6F NON-ABBOTT GUIDE SHEATH (INNER DIAMETER 0.070"). HOWEVER, ABOUT 20CM INTO THE GUIDE, RESISTANCE WAS MET, AND THE DEVICE COULD NOT BE ADVANCED FURTHER. THE DEVICE WAS REMOVED AND WAS NOTED TO HAVE A HOLD IN THE CENTRAL DISC PORTION OF THE DEVICES. A REPLACEMENT SAME SIZE PLUG WAS USED WITH THE SAME 6F NON-ABBOTT GUIDE SHEATH (GUIDE NOT CHANGED AT THAT TIME); HOWEVER, THE SAME ISSUE OCCURRED. THERE WAS NO TORTUOSITY TO EXPLAIN THIS. THUS, THE GUIDE SIZE WAS INCREASED TO 7F NON-ABBOTT GUIDE SHEATH (INNER DIAMETER 0.081") GIVEN THAT INNER DIAMETER WAS THE SAME AS THE MINIMUM REQUIRED FOR THE DEVICE. AT ABOUT 50CM INTO THE GUIDE SHEATH, THE DEVICE WOULD NOT ADVANCE ANY FURTHER. SIMILAR OUTCOME WITH A HOLE IN THE SHOULDER OF THE CENTRAL DISC OF THE AVP-2. ANOTHER 7F GUIDE WAS BENCH TESTED ON THE BACK TABLE (NOTE THIS WAS A CORDIS 7F GUIDE). THERE WAS NO RESISTANCE TO ADVANCING THE DEVICE. AFTER D

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310681 ↗
• MalfunctionDec 12, 2023Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT ON 25 OCTOBER 2023, AN AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT INTO AORTIC PARAVALVULAR LEAK (PVL) IN THE NON-CORONARY CUSP. IT WAS INDICATED THAT THERE WAS A PRE-EXISTING 23MM NON-ABBOTT AORTIC VALVE IMPLANTED. A 12MM AMPLATZER VASCULAR PLUG II WAS ADVANCED THROUGH 6F NON-ABBOTT GUIDE SHEATH (INNER DIAMETER 0.070"). HOWEVER, ABOUT 20CM INTO THE GUIDE, RESISTANCE WAS MET, AND THE DEVICE COULD NOT BE ADVANCED FURTHER. THE DEVICE WAS REMOVED AND WAS NOTED TO HAVE A HOLD IN THE CENTRAL DISC PORTION OF THE DEVICES. A REPLACEMENT SAME SIZE PLUG WAS USED WITH THE SAME 6F NON-ABBOTT GUIDE SHEATH (GUIDE NOT CHANGED AT THAT TIME); HOWEVER, THE SAME ISSUE OCCURRED. THERE WAS NO TORTUOSITY TO EXPLAIN THIS. THUS, THE GUIDE SIZE WAS INCREASED TO 7F NON-ABBOTT GUIDE SHEATH (INNER DIAMETER 0.081") GIVEN THAT INNER DIAMETER WAS THE SAME AS THE MINIMUM REQUIRED FOR THE DEVICE. AT ABOUT 50CM INTO THE GUIDE SHEATH, THE DEVICE WOULD NOT ADVANCE ANY FURTHER. SIMILAR OUTCOME WITH A HOLE IN THE SHOULDER OF THE CENTRAL DISC OF THE AVP-2. ANOTHER 7F GUIDE WAS BENCH TESTED ON THE BACK TABLE (NOTE THIS WAS A CORDIS 7F GUIDE). THERE WAS NO RESISTANCE TO ADVANCING THE DEVICE. AFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310643 ↗
• InjuryDec 6, 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 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. SOFTE

  Patient problems: Obstruction/Occlusion

  MAUDE report 18278450 ↗
• 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 6 MONTH OLD PATIENT WEIGHING 5.8 KG. IT WAS REPORTED THAT ON AN UNKNOWN DATE, AN 10MM 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 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, CORRECT OCCLUDER CHOICE, PROPER TECHNIQU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268512 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, ¿INTERMEDIATE AND LONG-TERM FOLLOW-UP OF TRANSCATHETER CLOSURE OF CONGENITAL CORONARY CAMERAL FISTULAS IN INFANTS AND CHILDREN: EXPERIENCE FROM A SINGLE CENTER¿, WAS REVIEWED. THE ARTICLE PRESENTED A CASE STUDY OF A 1.08-YEAR-OLD, 9.5KG PATIENT WITH A CORONARY CAMERAL FISTULA. IT WAS REPORTED THAT ON AN UNKNOWN DATE, A 10MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO OCCLUDE A CORONARY CAMERAL FISTULA. DURING PROCEDURE, THE PATIENT EXPERIENCED ACUTE MYOCARDIAL INFARCTION. THE ARTICLE CONCLUDED THAT TCC OF CCFS IN INFANTS AND CHILDREN APPEARS TO BE EFFECTIVE AND IS ASSOCIATED WITH A RELATIVELY LOW COMPLICATION RATE. LARGE CCFS AND GIANT CORONARY ARTERY ANEURYSMS (CAAS) REPRESENT A HIGHER RISK OF BOTH ACUTE AND INTERMEDIATE AND LONG-TERM ADVERSE EVENTS AFTER CLOSURE. [THE PRIMARY AND CORRESPONDING AUTHOR WAS ZHIWEI ZHANG, DEPARTMENT OF PEDIATRIC CARDIOLOGY, GUANGDONG CARDIOVASCULAR INSTITUTE, GUANGDONG PROVINCIAL PEOPLE¿S HOSPITAL (GUANGDONG ACADEMY OF MEDICAL SCIENCES), SOUTHERN MEDICAL UNIVERSITY, GUANGDONG PROVINCIAL KEY LABORATORY OF SOUTH CHINA STRUCTURAL HEART DISEASE, GUANGZHOU, 510100, CHINA, WITH CORRESPONDING EMAIL: [email protected]]

  Patient problems: Myocardial Infarction

  MAUDE report 17909610 ↗
• InjuryAug 23, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, A 10MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT IN THE LEFT POPLITEAL ARTERY TO LIGATE FOR A CARDIOPULMONARY BYPASS SURGERY. DURING PROCEDURE, HEPARIN WAS ADMINISTERED. THE VESSEL WAS MEASURED APPROXIMATELY 6.5MM, AND THE SIZE OF THE DEVICE WAS DETERMINED VIA IMAGING. THE 10MM AMPLATZER VASCULAR PLUG II WAS SUCCESSFULLY DEPLOYED. A SECOND 10MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR DEPLOYMENT. WHILE DEPLOYING THE SECOND PLUG, THE PLUG EMBOLIZED TO THE LEFT PULMONARY ARTERY. THERE WAS NO REPORTED BLOCKAGE OF BLOOD FLOW. A NEW 16MM AMPLATZER VASCULAR PLUG II WAS SUCCESSFULLY DEPLOYED. AFTER THE DEPLOYMENT, THE PHYSICIAN TRIED MULTIPLE ATTEMPTS TO RETRIEVE THE EMBOLIZED PLUG, AND THE PLUG WAS SUCCESSFULLY AND EMERGENTLY REMOVED FROM THE PULMONARY ARTERY VIA GOOSENECK SNARE. THE FIRST AND THIRD PLUG REMAIN IMPLANTED IN THE PATIENT'S LEG. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17606876 ↗
• 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 8-MONTH-OLD, 5KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 6.5MM, AMPULLA DIAMETER = 9MM, DUCTAL LENGTH = 10.1MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 10MM 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 10-8MM AMPLATZER DUCT OCCLUDER I. THE SECOND DEVICE WAS IMPLANTED SUCCESSFULLY WITH A REPORTED 5MMHG GRADIENT BETWEEN THE ASCENDING AND DESCENDING AORTA. [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]]. PERI-PROCEDURAL COMPLICATIONS INCLUDED RESIDUAL SHUNT, SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17545055 ↗
• InjuryAug 14, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  HOLD FOR KP. 8.15.23. 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 4-YEAR-OLD, 12KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 7.1MM, AMPULLA DIAMETER = 10MM, DUCTAL LENGTH = 10MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 10MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER IMPLANT, IT WAS NOTED THE DEVICE HAD EMBOLIZED INTO THE PULMONARY ARTERY. A DECISION WAS MADE TO ADMIT THE PATIENT FOR SURGICAL RETRIEVAL OF THE DEVICE AND TREATMENT OF THE PDA VIA SURGICAL LIGATION. [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 DEVICE EMBOLIZATION, SURGICAL INTERVENTION, HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17544492 ↗
• MalfunctionAug 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2023-03548. 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, 5.5KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 4.2MM, AMPULLA DIAMETER = 7.7MM, DUCTAL LENGTH = 11.2MM. IT WAS REPORTED ON AN UNKNOWN DATE, A 12MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO OCCLUDE A PDA. AFTER THE DEVICE WAS IMPLANTED, IT WAS NOTED THERE WAS AN ELONGATION OF THE DEVICE CAUSING LEFT PULMONARY ARTERY STENOSIS DUE TO DEVICE OVERSIZING. A DECISION WAS MADE TO ADDITIONALLY IMPLANT A 10MM AMPLATZER VASCULAR PLUG II. THE SECOND DEVICE WAS IMPLANTED SUCCESSFULLY WITH A REPORTED MILD RESIDUAL SHUNTING. [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]] 10MM AMPLATZER VASCULAR PLUG II, PERI-PROCEDURAL COMPLICATIONS INCLUDED RESIDUAL SH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17544160 ↗
• InjuryMay 31, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON 8 MAY, 2023 AN AMPLATZER VASCULAR PLUG II WAS IMPLANTED UTILIZING AN UNKNOWN DELIVERY SYSTEM. THE DEVICE THEN EMBOLIZED TO THE PULMONARY ARTERY. LATER, THE DEVICE WAS RETRIEVED VIA A SNARE.

  Patient problems: Embolism/Embolus

  MAUDE report 17028572 ↗
• InjuryNov 4, 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, A 14X5MM AMPLATZER VALVULAR PLUG 3 AND A 10MM AMPLATZER VASCULAR PLUG 2 WERE IMPLANTED INTO A PATIENT TO CLOSE AN AORTIC PARAVALVULAR LEAK. THE DEVICE WAS SIZED USING TRANSTHORACIC ECHOCARDIOGRAM (TTE). DURING THE PROCEDURE, AFTER IMPLANTATION, IT WAS NOTED THAT THERE WAS A MILD RESIDUAL LEAK. IT WAS DECIDED TO IMPLANT A THIRD DEVICE. UPON ADVANCEMENT OF THE 6F DELIVERY SHEATH, BOTH THE AMPLATZER VALVULAR PLUG 3 AND AMPLATZER VASCULAR PLUG 2 EMBOLIZED INTO THE ILIAC ARTERY. THE DEVICES WERE SNARED AND REMOVED FROM PATIENT ANATOMY. A NEW 14X5MM AMPLATZER VALVULAR PLUG 3 AND A 12MM AMPLATZER VASCULAR PLUG 2 WERE SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTED TO BE STABLE. IT IS BELIEVED THAT THE DEVICE EMBOLIZED DUE TO THE SHEATH ADVANCEMENT OF THE THIRD DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE DUE TO DEVICE RETRIEVAL, AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738984 ↗
• InjuryAug 22, 2022Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, A 10MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR AN INTERNAL ILIAC ARTERY EMBOLIZATION PROCEDURE. IT WAS NOTED THAT DURING PROCEDURE THE AMPLATZER VASCULAR PLUG 2 WAS UNABLE TO BE LOADED THROUGH A 4.5FR PARENT GUIDE CATHETER. THE DECISION WAS MADE TO REPLACE THE 4.5FR GUIDE CATHETER WITH AN UNKNOWN 7F GUIDE CATHETER. THE 10MM AMPLATZER VASCULAR PLUG 2 WAS ABLE TO BE LOADED THROUGH THE 7F GUIDE CATHETER, BUT A THROMBUS ADHERED TO THE AMPLATZER VASCULAR PLUG 2 PREVENTING IT FROM BEING ABLE TO ADVANCE TO INTERNAL ILIAC ARTERY. THE DECISION WAS MADE TO REPLACE THE 10MM AMPLATZER VASCULAR PLUG 2 WITH A 12MM AMPLATZER VASCULAR PLUG 2 TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15271683 ↗
• InjuryJul 27, 2022Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 A 10MM AMPLATZER VASCULAR PLUG II WAS SUCCESSFULLY IMPLANTED USING A 5F NON-ABBOTT DELIVERY SHEATH. THREE MINUTES AFTER THE DEVICE WAS DEPLOYED THE DEVICE EMBOLIZED INTO THE ARTERIAL DUCT, DISCOVERED VIA ANGIOGRAPHY. CONTRAST WAS INJECTED AND IT WAS NOTED THAT THE CONTRAST WAS STILL ABLE TO PASS THROUGH THE TARGET VESSEL. THE DEVICE WAS REMOVED VIA TRANSCATHETER SNARE AND REPLACED WITH A NON-ABBOTT DEVICE. IT WAS NOTED THAT THE DIAMETER SELECTION OF THE DEVICE WAS SUITABLE, BUT THE LENGTH WAS TOO LONG, WHICH LEADS TO POOR ADHESION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS STABLE AND DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116087 ↗
• DeathMay 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS BEING CONSERVATIVELY REPORTED AS THE CAUSE OF THE PATIENT'S DEATH IS UNKNOWN. IT WAS REPORTED THAT ON (B)(6) 2022 , 12 MM AMPLATZER VSD MUSCULAR (VSD) AND A 10 MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT IN A (B)(6) FEMALE PATIENT WITH PRIOR VENTRICULAR SEPTAL DEFECT (VSD) SURGICAL PATCH REPAIR. THE VENTRICULAR SEPTUM WAS THEN DETERMINED TO BE MULTI-FENESTRATED VIA TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE 12MM AMPLATZER VSD DEVICE WAS POSITIONED SUCCESSFULLY AND WITHOUT COMPLICATION THROUGH ONE OF THE DEFECTS AND DEPLOYED VIA INTERNAL JUGULAR VEIN (IJ) ACCESS. ANOTHER TUNNEL TYPE DEFECT WAS THEN CROSSED WITH A GUIDEWIRE FROM THE RIGHT VENTRICLE (RV) SIDE TO THE LEFT VENTRICLE (LV ) AND CLOSED WITH A 10 MM AMPLATZER VASCULAR PLUG II. BOTH DEVICES WERE RELEASED WITH GOOD RESULT. THE PATIENT THEN BEGAN TO HAVE ST-ELEVATION AND A MARKED DECREASE IN BLOOD PRESSURE. THE TEAM BEGAN CARDIOPULMONARY RESUSCITATION (CPR) AND PERFORMED ALL NECESSARY PROTOCOLS TO ALLEVIATE THE SYMPTOMS, BUT WERE INEVITABLY UNABLE TO REVERSE THE PATIENT'S CONDITION. THE PATIENT EXPIRED AFTER 30 + MINUTES OF CPR WITH ANESTHESIA SUPPORT ON (B)(6) 2022. THE TEAM AND CARDIOVASCULAR SURGEO

  Patient problems: Arrhythmia

  MAUDE report 14388240 ↗
• InjuryDec 15, 2021Migration or Expulsion of Device; Use of Device Problem; Migration or Expulsion of Device; Use of Device Problem

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00564. ON AN UNKNOWN DATE, TWO 10MM AMPLATZER VASCULAR PLUG II WERE SUCCESSFULLY IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE, BOTH PLUGS WERE FOUND TO HAVE MIGRATED DOWN INTO THE ABDOMINAL AORTA. THE PATIENT WAS BROUGHT TO SURGERY WHERE THE PLUGS WERE SUCCESSFULLY SNARED AND REPLACED WITH TWO LARGER PLUGS TO RESOLVE THE EVENT. THE PHYSICIAN THOUGHT THE EVENT WAS DUE TO THE PLUGS USED BEING TOO SMALL IN DIAMETER OR THAT THE PATIENTS ANATOMY CHANGED, THERE WAS NO ALLEGATION AGAINST THE ABBOTT DEVICES. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015215 ↗
• InjuryDec 15, 2021Migration or Expulsion of Device; Use of Device Problem; Migration or Expulsion of Device; Use of Device Problem

  RELATED MANUFACTURER REPORT NUMBER: 2135147-2021-00565. ON AN UNKNOWN DATE, TWO 10MM AMPLATZER VASCULAR PLUG II WERE SUCCESSFULLY IMPLANTED IN A PATIENT. ON AN UNKNOWN DATE, BOTH PLUGS WERE FOUND TO HAVE MIGRATED DOWN INTO THE ABDOMINAL AORTA. THE PATIENT WAS BROUGHT TO SURGERY WHERE THE PLUGS WERE SUCCESSFULLY SNARED AND REPLACED WITH TWO LARGER PLUGS TO RESOLVE THE EVENT. THE PHYSICIAN THOUGHT THE EVENT WAS DUE TO THE PLUGS USED BEING TOO SMALL IN DIAMETER OR THAT THE PATIENTS ANATOMY CHANGED, THERE WAS NO ALLEGATION AGAINST THE ABBOTT DEVICES. THE PATIENT IS STABLE. NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015213 ↗
• InjuryJun 15, 2021Off-Label Use; Material Twisted/Bent; Off-Label Use; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, A 8 MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, THE DEVICE WAS UNABLE TO ADVANCE/DEPLOY. THE DEVICE WAS REMOVED AND REPLACED WITH A 10 MM AMPLATZER VASCULAR PLUG II. THE REPLACEMENT DEVICE WAS POSITIONED, BUT WHEN DEPLOYED, APPEARED TO BECOME TWISTED AND CONTORTED. THE DEVICE WAS SNARED OUT TO RESOLVE THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12004150 ↗
• InjuryApr 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2021, A 10 MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. DURING THE IMPLANT PROCEDURE, WHILE THE DEVICE WAS PARTIALLY DEPLOYED FOR POSITIONING, THE DEVICE BECAME DETACHED FROM THE DELIVERY CABLE. A SNARE WAS THEN USED TO RECAPTURE THE DEVICE INTO THE DELIVERY SYSTEM. A 12 MM AMPLATZER VASCULAR PLUG II WAS THEN ATTEMPTED, BUT WAS FOUND TO BE TOO LARGE. NO DEVICE WAS IMPLANTED AND THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE, HOWEVER THERE WAS A CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11685888 ↗
• InjuryFeb 23, 2021Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  ON(B)(6) 2021, A 10MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT IN A CANINE PATIENT TO OCCLUDE A PDA. AS THE PHYSICIAN WAS POSITIONING THE DEVICE, THE PLUG RELEASED BEFORE INTENDED. THE DEVICE WAS ATTEMPTED TO BE SNARED, HOWEVER IT WAS UNSUCCESSFUL AND THE PLUG REMAINS IN THE PATIENT'S LEFT PULMONARY ARTERY (LPA). IT WAS REPORTED THAT THERE ARE NO PLANS TO RETRIEVE THE DEVICE AND THE PATIENT WILL BE MONITORED. WHILE THIS DEVICE IS INTENDED FOR HUMAN USE AND WAS USED OFF-LABEL IN A CANINE PATIENT, THIS EVENT IS BEING CONSERVATIVELY REPORTED. IT WAS REPORTED THAT THE PATIENT IS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369137 ↗