AMPLATZER™ 9-AVP2-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00811806010397), received between Aug 29, 2018 and Sep 19, 2025 — classified as 13 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (9 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. How this data works · Data updated Oct 13, 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.

• InjurySep 19, 2025Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON A (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED. 4 CLIPS WERE IMPLANTED. ON A UNKNOWN DATE POST PROCEDURE, MODERATE SEVERE MITRAL REGURGITATION REMAINED THAT WAS STILL CAUSING PATIENT SYMPTOMS. ONE OF THE CLIPS WAS REPORTED TO HAVE REOPENED (CLIP OPENED WHILE LOCKED (COWL). PATIENT ALSO HAD A BI-DIRECTIONAL SHUNT FROM PREVIOUS TRANSSEPTAL PUNCTURE. ON (B)(6) 2025, IT WAS DECIDED TO IMPLANT A 12MM AMPLATZER VASCULAR PLUG 2 TO REDUCE THE MR UTILIZING A 7F NON-ABBOTT DELIVERY SHEATH. GAP OF PLANNED TREATMENT AREA WAS 6X9MM. SIZING DETERMINED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. THE PLUG WAS DEPLOYED BUT IMMEDIATELY AFTER RELEASE IT EMBOLIZED AND TRAVELED TO THE FEMORAL ARTERY WHERE IT WAS RETRIEVED VIA SNARE. THE PATIENT EXPERIENCED NO CLINICAL SIGNS OR SYMPTOMS AND THERE WAS NO BLOCKAGE OF BLOOD FLOW. A 16MM AMPLATZER VASCULAR PLUG 2 WAS THEN IMPLANTED SUCCESSFULLY. IT WAS THOUGHT THE EMBOLIZATION WAS DUE TO MIS-SIZING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23098053 ↗
• MalfunctionAug 26, 2025Difficult to Fold, Unfold or Collapse; Separation Problem; Difficult to Fold, Unfold or Collapse; Separation Problem

  USER FACILITY MEDWATCH REPORT (B)(4) RECEIVED THAT STATES "THE PLUG KEPT TWISTING AND TWISTING. IT WOULD NOT UNSCREW". IT WAS REPORTED THAT ON (B)(6) 2025, A 12MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR A PROCEDURE. DURING PROCEDURE, IT WAS NOTED THAT THE PLUG KEPT TWISTING AND TWISTING AND IT WOULD NOT UNSCREW. 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 22898546 ↗
• MalfunctionJul 17, 2025Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533018 ↗
• MalfunctionOct 25, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2024, A 12MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, DEVICE MALFORMATION (COBRA SHAPE) WAS SEEN IN CASE AND WAS REMOVED FROM THE PATIENT PRIOR TO RELEASED FROM THE CABLE. NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT AND NO ANGULATION OR KINK NOTICED IN THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533835 ↗
• MalfunctionJun 24, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER VASCULAR PLUG II WAS SELECTED TO EMBOLIZED A DEFEAT. DURING THE SPLENIC ARTERY EMBOLIZATION TREATMENT, THE VASCULAR PLUG REACHES THE LESION, AFTER THE VASCULAR PLUG WAS RELEASED, THE ANCHOR POINT WAS TOO LONG AND COVERED THE RETAINED BRANCH VESSELS THAT SHOULDN'T BE EMBOLIZED, WHICH ALSO AFFECTED THE BLOOD FLOW. THE DEVICE WAS REPLACED WITH A NON-ABBOTT DEVICE THAT COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT IS STABLE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 19593594 ↗
• MalfunctionMar 5, 2024Separation Problem; Premature Separation; Separation Problem; Premature Separation

  IT WAS REPORTED THAT A 12MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A NON-ABBOTT DELIVERY SYSTEM. DURING DEVICE PREPARATION, THE DEVICE WAS PREPARED PER IFU. THE PHYSICIAN CHECKED THE CABLE CONNECTION AND FOUND NO ISSUES. DURING THE PROCEDURE IT WAS OBSERVED THAT THE DEVICE PREMATURELY SEPARATED FROM THE DELIVERY CABLE AND WAS STUCK IN THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836783 ↗
• MalfunctionJan 18, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR TREATMENT OF AN ENDO LEAK IN A TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) CASE. DURING PREPARATION, THE DEVICE WAS PROPERLY PREPARED PER INSTRUCTIONS FOR USE (IFU). DURING PROCEDURE, IT WAS NOTED THAT THE DEVICE DIDN'T OPEN. THE DEVICE WAS REMOVED FORM THE PATIENT PRIOR TO RELEASE. THE PROCEDURE WAS TERMINATED. 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 RECOVERING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536493 ↗
• 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 18311168 ↗
• 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310599 ↗
• 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 18310495 ↗
• MalfunctionSep 27, 2023Delivered as Unsterile Product; Material Deformation; Delivered as Unsterile Product; Material Deformation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826192 ↗
• InjuryAug 14, 2023Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method; Difficult to Fold, Unfold or Collapse; Improper or Incorrect Procedure or Method

  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]]. 12MM AMPLATZER VASCULAR PLUG II, PERI-PROCEDURAL COMPLICATIONS INCLUDED SURGICAL INTERVENTION, OBSTRUCTION/OCCLUSION, DEFORMATION, IMPROPE

  Patient problems: Obstruction/Occlusion

  MAUDE report 17543625 ↗
• 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 6-MONTH-OLD, 6KG PATIENT WITH THE FOLLOWING PATENT DUCTUS ARTERIOSUS (PDA) MEASUREMENTS: MINIMAL DUCTUS DIAMETER = 6.6MM, AMPULLA DIAMETER = 9MM, DUCTAL LENGTH = 7MM. 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 A RESIDUAL SHUNT. A DECISION WAS MADE TO ADDITIONALLY IMPLANT A 14MM 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 17541407 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, "A RARE CASE OF TRANSCATHETER CLOSURE OF BOTH INLET AND OUTLET OF A LEFT CORONARY ARTERY-TO-LEFT VENTRICULAR FISTULA WITH GIANT CORONARY ARTERY ANEURYSM", WAS REVIEWED. THIS RESEARCH ARTICLE REPORTED A CASE STUDY ON A 8 YEAR OLD PATIENT PRESENTED TO THE HOSPITAL DUE TO CONTINUOUS CARDIAC MURMUR. ON ADMISSION, THE PATIENT'S TEMPERATURE WAS 36.8°C, AND HER BLOOD PRESSURE WAS 100/55 MMHG. THE PATIENT'S HEART RATE WAS 90 BPM. OXYGEN SATURATION WAS 100%. CONTINUOUS MURMUR COULD BE HEARD AT THE 4TH¿5TH INTERCOSTAL SPACE NEAR THE LEFT STERNAL BORDER. ELECTROCARDIOGRAPHY (ECG) SHOWED NORMAL SINUS RHYTHM. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) REVEALED A SEVERE DILATION OF THE LCA OSTIUM WITH A GIANT ANEURYSMAL CORONARY ARTERY LOCATED ABOVE THE INTRAVENTRICULAR SEPTUM (IVS). THE CORONARY ARTERY WAS DRAINING INTO LV CAVITY THROUGH AN ORIFICE WITH DIAMETER OF 4.0 MM. COLOR DOPPLER FLOW IMAGING DETECTED A CONTINUOUS DOUBLE-PHASE TURBULENT SPECTRUM AT THE ORIFICE, SUGGESTING THE PRESENCE OF AN LCA-TO-LV FISTULA. SINCE NO SIGN OF LEFT VENTRICULAR OVERLOAD WAS PRESENT, THE SHUNT WAS CONSIDERED SMALL DEGREE. THREE-DIMENSIONAL COMPUTED TOMOGRAPHY (3D-CT) SCAN CONFIRMED THAT THE FISTULA W

  Patient problems: Arrhythmia; Obstruction/Occlusion

  MAUDE report 17263133 ↗
• MalfunctionMay 9, 2023Migration or Expulsion of Device; Patient Device Interaction Problem; Migration or Expulsion of Device; Patient Device Interaction Problem

  CLINICAL INFORMATION: CRD_1008 - AV-MDR, PATIENT SITE ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, A 12MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT TO PLUG A PARAVALVULAR LEAK (PVL). PRIOR TO 12MM DEVICE IMPLANT, A 10MM AMPLATZER VASCULAR PLUG II (8372531) WAS SUCCESSFULLY IMPLANTED IN ANOTHER NEARBY PVL. WHILE ATTEMPTING TO IMPLANT THE 12MM DEVICE (8368984), DEVICE DEPLOYMENT WAS SUCCESSFUL. HOWEVER, LEAKAGE WAS SEEN AROUND THE PLUG AND AFTER THE DEVICE WAS IN PLACE, IT POPPED OUT OF THE PVL. AFTERWARDS, THE DEVICE WAS EXPLANTED AND A SECOND 10MM AMPLATZER VASCULAR PLUG II (7810738) WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16897452 ↗
• InjuryMar 3, 2023Difficult to Advance; Patient Device Interaction Problem; Difficult to Advance; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 12MM AMPLATZER VASCULAR PLUG II ((B)(4)) WAS CHOSEN FOR IMPLANT IN AN EMERGENCY LEFT INTERNAL ILIAC ARTERY ANEURYSM RUPTURE CASE USING A 5F NON-ABBOTT DELIVERY SYSTEM. AT THE START OF THE PROCEDURE, 10,000 UNITS OF HEPARIN WERE ADMINISTERED INTRAVENOUSLY. AFTER THE DELIVERY SYSTEM WAS DELIVERED TO THE LEFT ANEURYSM RUPTURE SITE, IT WAS ATTEMPTED TO DELIVER THE DEVICE, BUT STRONG RESISTANCE WAS ENCOUNTERED NEAR THE RIGHT COMMON ILIAC ARTERY. THE DEVICE WAS NOT ABLE TO BE DELIVERED TO THE ANEURYSM SITE AND WAS NOT DEPLOYED INSIDE THE PATIENT. IT WAS NOTED THAT THERE WAS MILD TORTUOSITY OF THE RIGHT COMMON ILIAC ARTERY. IT WAS BELIEVED THAT THE LUMEN WAS NOT FLAT, AND A DEFECT WAS SUSPECTED IN THE DEVICE. THE DEVICE ((B)(4) ) WAS REMOVED FROM THE PATIENT. IT WAS OBSERVED THAT THE DEVICE ((B)(4)) HAD A SMALL AMOUNT OF A THROMBUS-LIKE SUBSTANCE WAS ATTACHED. A NEW 12MM AMPLATZER VASCULAR PLUG II ((B)(4)) WAS CHOSEN FOR IMPLANT. THE DEVICE WAS DELIVERED TO THE RIGHT COMMON ILIAC ARTERY WITHOUT RESISTANCE AND PLACED WITHOUT ISSUE. THE PROCEDURE WAS CONCLUDED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY AND HE PATIENT REMAINED HEMODYNAMICALLY STABLE THR

  Patient problems: Thrombosis/Thrombus

  MAUDE report 16478443 ↗
• MalfunctionDec 16, 2022Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2022, A 12MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT WITH A 6FR NON-ABBOTT DELIVERY SHEATH. THE DEVICE WAS UNABLE TO GO THROUGH THE 6FR SHEATH WHILE IT WAS IN THE CATHETER SO A 7FR NON-ABBOTT SHEATH WAS ATTEMPTED TO BE USED AS A REPLACEMENT. DURING THE PROCESS OF SWITCHING TO THE NEW SHEATH THE DEVICE FELL OF THE WIRE AND COULD NO LONGER BE USED. THE DEVICE WAS REPLACED WITH A 14MM AMPLATZER VASCULAR PLUG II USING THE 7FR NON-ABBOTT SHEATH. DURING THE IMPLANT PROCESS IT WAS DISCOVERED THAT THE 14MM DEVICE WAS TOO BIG. IT WAS REMOVED AND REPLACED WITH A 10MM DEVICE USING THE SAME 7FR NON-ABBOTT SHEATH AND A NON-ABBOTT (JR4) GUIDE CATHETER. THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996430 ↗
• InjuryOct 17, 2022Premature Separation; Premature Separation

  AN ARTICLE FROM THE 58TH ANNUAL MEETING OF JAPANESE SOCIETY OF PEDIATRIC CARDIOLOGY AND CARDIAC SURGERY CONFERENCE, ABSTRACT P. I-P2-6-02; REPORT A CASE OF 4YRS AND 3 MONTH OLD MALE INFANT (HEIGHT 107CM, WEIGHT 18.1KG) WITH CONGENITAL CORONARY ARTERY FISTULA DIAGNOSED WITH CARDIAC MURMUR SINCE BIRTH. AT ONE YEAR AND 3 MONTH OLD, CORONARY ANGIOGRAPHY WAS CONDUCTED. QP/QS=1.9, THE RIGHT CORONARY ARTERY (RCA) AND LEFT CIRCUMFLEX ARTERY (LCX) FLOWED INTO THE SAME OPENING IN THE POSTERIOR RIGHT VENTRICLE. IT WAS FINALLY DIAGNOSED AS DISTAL BILATERAL CORONARY ARTERIOVENOUS FISTULA. THE MALE INFANT HAD ANTERIOR CHEST PAIN SINCE AGE 3. IT WAS DECIDED THAT THE INFLOW PORTION OF RIGHT VENTRICLE WAS REQUIRED TO BE EMBOLIZED. A 5F NON-ABBOTT DEVICE WAS DELIVERED AND PASSED THROUGH THE NARROWEST AREA OF RCA. A 12MM AMPLATZER VASCULAR PLUG 2 WAS ATTEMPTED TO BE IMPLANTED, THE PLUG FELL OFF ON MULTIPLE ATTEMPTS. IT WAS FOUND THAT THE NON-ABBOTT DEVICE SHEATH DID NOT ACTUALLY CROSSED OVER THE NARROWEST AREA AND MADE RCA COMPRESSED. THE 12MM AMPLATZER VASCULAR PLUG 2 WAS PLACED WITH UNKNOWN SIZE AMPLATZER VASCULAR PLUG 2 WHICH WAS INSERTED AND DEPLOYED IN THE VESSEL BY ANTEGRADE APPROACH. AFTER THE

  Patient problems: Angina

  MAUDE report 15617450 ↗
• MalfunctionSep 14, 2022Off-Label Use; Product Quality Problem; Off-Label Use; Product Quality Problem

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15420390 ↗
• InjuryJul 27, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, A 12MM AMPLATZER VASCULAR PLUG 2 (AVP2) WAS SUCCESSFULLY IMPLANTED USING A 6F NON-ABBOTT DELIVERY SHEATH. REPORTEDLY, 3 MINUTES AFTER IMPLANT THE 12MM AVP2 EMBOLIZED INTO THE PATIENT'S ARTERIAL DUCT. CONTRAST WAS INJECTED AND IT WAS NOTED THAT THE CONTRAST WAS STILL ABLE TO PASS THROUGH THE TARGET VESSEL. THE EMBOLIZATION WAS CONFIRMED VIA ANGIOGRAPHY EXAMINATION. THE DECISION WAS MADE TO EXPLANT THE 12MM AVP2 USING A TRANSCATHETER SNARE AND IMPLANT A REPLACEMENT NON-ABBOTT DEVICE. THE TARGET VESSEL WAS SUCCESSFUL EMBOLIZED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE IMPLANT/EXPLANT PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE IMPLANT PROCEDURE. THE PATIENT WAS STABLE AND DISCHARGED AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15116967 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ARTICLE, ¿INTERNAL ILIAC ARTERY ANEURYSM RUPTURES WITH NO VISUALIZED ENDOLEAK 2 YEARS AFTER ENDOVASCULAR REPAIR¿, WAS REVIEWED. THE RESEARCH ARTICLE PRESENTS A CASE STUDY OF A 83-YEAR-OLD MALE PRESENTED WITH RIGHT IIA ANEURYSM OF 36 MM IN DIAMETER ON AN UNKNOWN DATE. HIS COMORBIDITIES INCLUDED HYPERTENSION, ATRIAL FIBRILLATION, AND CHRONIC HEART DISEASE, AND HAD TAKEN WARFARIN. UNDERWENT ENDOVASCULAR REPAIR FOR THE TREATMENT OF IIA ANEURYSM, INCLUDING INSERTION OF A STENT GRAFT FROM THE COMMON TO THE EXTERNAL ILIAC ARTERY FOLLOWING EMBOLIZATION OF THE RIGHT IIA. NO ENDOLEAK WAS SEEN ON COMPUTED TOMOGRAPHY (CT) 5 DAYS AFTER THE ENDOVASCULAR REPAIR. TWO YEARS AFTER THE FIRST TREATMENT, CT REVEALED THAT THE ANEURYSM GRADUALLY EXPANDED TO A DIAMETER OF 50 MM WITHOUT EVIDENCE OF ENDOLEAK. ANGIOGRAPHY SHOWED NO ENDOLEAK. CONSIDERING ADVANCED AGE AND COMORBIDITIES, FURTHER INTERVENTION WAS NOT OFFERED AT THAT TIME DUE TO NO FINDINGS OF ENDOLEAK. ONE MONTH AFTER, THE PATIENT TOOK A BLOOD TEST REGULARLY BECAUSE OF THE ADMINISTRATION OF THE ORAL INTAKE OF WARFARIN. ALTHOUGH THE PATIENT HAD NO SYMPTOMS SUCH AS ABDOMINAL OR BACK PAIN, ANEMIA WAS DETECTED VIA THE BLOOD TEST. HEMOGLOBIN LEVE

  Patient problems: Anemia; Aneurysm; Atrial Fibrillation

  MAUDE report 14637343 ↗
• MalfunctionSep 16, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2021, A 12 MM AMPLATZER VASCULAR PLUG II DEVICE WAS CHOSEN FOR A THORACIC AORTIC ANEURYSM (TAA) CASE. DURING PROCEDURE, THE DEVICE WAS ATTEMPTED TO BE DEPLOYED IN THE RIGHT SUBCLAVIAN ARTERY, BUT THE DEVICE DID NOT TAKE THE PROPER SHAPE. THE DEVICE WAS REMOVED FROM THE PATIENT, AND THE CASE WAS ABANDONED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481267 ↗
• InjuryJun 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 12MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR USE IN THE LEFT SUBCLAVIAN FOR A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) CASE ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN WENT THROUGH THE RIGHT GROIN AND INTO THE SUBCLAVIAN. AS THE PHYSICIAN WAS REPOSITIONING THE PLUG IT SOME HOW CAME OFF THE DELIVERY WIRE. IT WAS LEFT HANGING PARTIALLY IN THE SUBCLAVIAN AND PARTIALLY IN THE AORTA. THE PHYSICIAN THEN HAD TO STICK THE LEFT BRACHIAL AND SNARE THE PLUG AND PUT IT IN THE CORRECT PLACE. THE PATIENT DID NOT EXPERIENCE ANY SERIOUS INJURIES AND THE PLUG REMAINS IMPLANTED. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE ENTIRE PROCEDURE, BUT THERE WAS A 30 MINUTE CLINICALLY SIGNIFICANT DELAY TO THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11961822 ↗
• InjuryDec 16, 2020Material Deformation; Material Deformation

  ON (B)(6) 2020, A 12MM AMPLATZER VASCULAR PLUG II(AVPII) WAS SELECTED FOR EMBOLIZATION IN THE LEFT SUBCLAVIAN ARTERY DURING THORACIC ENDOVASCULAR AORTIC REPAIR(TEVAR). VIA LEFT BRACHIAL ARTERY, THE AVPII WAS INSERTED INTO A 7FR FLEXOR ANSEL GUIDING SHEATH(BY COOK MEDICAL) AND WAS DEPLOYED IN THE TARGET VESSEL. HOWEVER, THE AVPII WAS NOT DEPLOYED IN ITS ORIGINAL FORM; THE AVPII SEEMED TO HAVE EXPANDED DIAGONALLY. THE AVPII WAS REPOSITIONED TWO TIMES, BUT THE ISSUE PERSISTED, AND THEREFORE, THE PHYSICIAN WITHDREW THE AVPII WITHOUT DETACHING FROM THE DELIVERY CABLE. A SAME-SIZED AVPII WAS DELIVERED TO THE TARGET VESSEL AND WAS ABLE TO BE DEPLOYED IN ITS USUAL SHAPE. THE REPLACEMENT AVPII WAS DETACHED FROM THE DELIVERY CABLE AND THE PROCEDURE WAS COMPLETED. OTHER THAN THE PROCEDURE DELAY, THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11016886 ↗
• InjuryDec 2, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ON (B)(6) 2019, A 10MM AMPLATZER VASCULAR PLUG II (AVPII) WAS SELECTED FOR IMPLANT. HOWEVER, THE DEVICE WAS MIS-SIZED AND DID NOT OCCLUDE OR PARTIALLY OCCLUDE THE DEFECT. THE AVPII WAS RECAPTURED AND REMOVED FROM THE PATIENT. A NEW 12MM AVPII WAS THEN SELECTED FOR IMPLANT. HOWEVER, THE 12MM AVPII WAS ALSO MIS-SIZED AND DID NOT OCCLUDE OR PARTIALLY OCCLUDE THE DEFECT. THE 12MM AVPII WAS RECAPTURED AND REMOVED FROM THE PATIENT. THEN, THE PATIENT WAS TRANSFERRED TO THE CTVS DEPARTMENT. THE CASE WAS ABANDONED DUE TO THE DEVICES BECAUSE THE INTENDED RESULT TO OCCLUDE THE DEFECT WAS NOT ACHIEVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9397739 ↗