AMPLATZER™ 9-AVP2-006Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00811806010366), received between Mar 6, 2019 and Dec 26, 2024 — classified as 1 death, 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Off-Label Use” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2024Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT 6F DELIVERY SHEATH. THE PATIENT DID NOT HAVE TORTUOUS ANATOMY. THE PLUG WAS DIFFICULT TO ADVANCE INTO THE DELIVERY SHEATH. THE SHEATH WAS ADVANCED TO THE DESIRED DEPLOYMENT SITE. WHEN THE SHEATH WAS PULLED BACK TO DEPLOY THE PLUG, IT WAS DISCOVERED THAT THE PLUG WAS NOT ATTACHED TO THE DELIVERY CABLE. UNDER FLUOROSCOPY, IT WAS DETERMINED THAT THE PLUG WAS LODGED IN THE PROXIMAL END OF THE SHEATH. THE SYSTEM WAS REMOVED FROM THE PATIENT. UPON REMOVAL, THE SHEATH WAS REPLACED, AND CANNULATION WAS ONCE AGAIN OBTAINED. THE DEVICE WAS REPLACED WITH COILS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE OF APPROXIMATELY ONE HOUR AS MULTIPLE SHEATHS WERE EXCHANGED IN ORDER TO DELIVER THE PLUG. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND DID NOT EXPERIENCE ANY ADVERSE EVENTS DURING OR AFTER THE PROCEDURE. THE PATIENT WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019570 ↗
• MalfunctionNov 6, 2024Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  IT WAS REPORTED THAT A 6MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT ON (B)(6) 2024 TO TREAT A TUBULAR ENDOLEAK USING A NON-ABBOTT DELIVERY SYSTEM. DURING IMPLANT THE DEVICE TOOK ON A COBRA SHAPE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO INTERACTIONS WITH CARDIAC STRUCTURES. THERE WERE NO ANGULATIONS OR KINKS NOTED ON THE DELIVERY SYSTEM. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622067 ↗
• MalfunctionJun 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER VASCULAR PLUG 2 WAS SELECTED FOR IMPLANT IN AN AORTIC PSEUDOANEURYSM INFLOW TRACT. AFTER ANGIOGRAPHY, THE VESSEL MEASURED APPROXIMATELY 4MM. DURING IMPLANT, THE PLUG WAS RELEASED FROM THE CABLE. FOLLOW UP ANGIOGRAPHY SHOWED THAT THE PLUG WAS UNABLE TO BLOCK THE VESSEL COMPLETELY, RESULTING IN A RESIDUAL SHUNT NEXT TO THE INSERTED PLUG. THE PLUG WAS REMOVED VIA SNARE AND REPLACED WITH AN 8MM AMPLATZER VASCULAR PLUG 2, WHICH WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED, AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19598603 ↗
• InjuryFeb 5, 2024Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6MM AMPLATZER VASCULAR PLUG 2 WAS CHOSEN FOR IMPLANT INTO PATENT DUCTUS ARTERIOSUS. THE DEVICE WAS OBSERVED TO EMBOLIZE AFTER RELEASE. THE DEVICE WAS REMOVED VIA SNARE. IN THE PHYSICIAN¿S OPINION, THE EMBOLIZATION WAS DUE TO INCORRECT DEVICE SIZE. A REPLACEMENT 08MM AMPLATZER VASCULAR PLUG WAS SUCCESSFULLY IMPLANTED. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18646548 ↗
• InjuryApr 22, 2022Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2022, A 6MM AMPLATZER VASCULAR PLUG II WAS CHOSEN FOR IMPLANT USING A NON-ABBOTT DELIVERY SYSTEM. THE DEVICE WAS SIZED USING ANGIOGRAM MEASUREMENTS THAT WERE TAKEN. DURING PROCEDURE, THE PLUG WAS IMPLANTED INTO THE PATENT DUCTUS ARTERIOSUS (PDA). ONCE THE DEVICE WAS RELEASED, THE PROXIMAL PORTION OF THE DEVICE SHIFTED TO THE MAIN PULMONARY ARTERY CAUSING AN OBSTRUCTION OF FLOW. THE DEVICE WAS ATTEMPTED TO BE RETRIEVED, BUT IT WAS NOT ABLE TO BE RETRIEVED IN THE CATHETERIZATION LABORATORY. THE PATIENT WAS REFERRED TO SURGERY FOR REMOVAL OF THE DEVICE AND CLOSURE OF THE PDA. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE EVENT. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THE CAUSE OF THE MIGRATION WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190867 ↗
• InjuryJan 6, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, A 6 MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS THE DEVICE THROUGH A 5F NON-ABBOTT CATHETER. THE PHYSICIAN NOTED THAT THE AMPLATZER VASCULAR PLUG II WAS DAMAGED, SO THE DEVICE WAS EXCHANGED FOR A NEW DEVICE, WHICH WAS SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE, HOWEVER THERE WAS A CLINICALLY SIGNIFICANT DELAY. THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175901 ↗
• MalfunctionNov 8, 2021Off-Label Use; Detachment of Device or Device Component; Material Deformation; Off-Label Use; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT A 6MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR AN IMPLANT ON (B)(6), 2021 FOR A PERSISTENT DUCTUS ARTERIOSUS WHICH EXTENDS FROM THE LEFT SUBCLAVIAN TO THE AORTA. THE PHYSICIAN CHECKED THAT THE CABLE WAS TIGHT ON THE OCCLUDER PRIOR TO USED. DURING DEPLOYMENT, THE PLUG WAS UNSCREWED FROM THE CABLE. THE LEFT DISC ON THE SUBCLAVIAN SIDE DEPLOYED BUT NOT THE RIGHT DISC ON THE AORTIC SIDE. THE PLUG WAS IN THE CANAL BUT WAS NOT CORRECTLY POSITIONED. THE PHYSICIAN TRIED TO RECOVER AND REPOSITION THE PLUG AND WAS UNSUCCESSFULLY. THE PHYSICIAN TRIED TO USE A NON-ABBOTT DEVICE AND WENT THROUGH THE ARTERIAL WAY TO RECOVER THE PLUG BUT WAS ALSO UNSUCCESSFULLY. THE PHYSICIAN WANTED TO STABILIZE THE PLUG SO AS NOT TO RISK HAVING CONSEQUENCES FOR THE PATIENT. IT WAS ALSO IMPOSSIBLE TO RECOVER THE PLUG VIA THE VENOUS WAY SINCE THE PLUG WAS CONNECTED TO THE DELIVERY SHEATH. SINCE THE PATIENT IS (B)(6) THE PHYSICIAN CANNOT CHANGE THE SHEATH TO A BIGGER SIZE, TOO DANGEROUS FOR THE PATIENT. THE PATIENT WAS SENT TO SURGERY AND THE PLUG WAS SURGICALLY REMOVED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT WAS INTUBATED AND S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775232 ↗
• InjuryJul 16, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  IT WAS REPORTED THAT ON (B)(6) 2021, A 6MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT INTO THE PATIENT'S PATENT DUCTUS ARTERIOSUS. POST DEPLOYMENT, THE DEVICE EMBOLIZED AND WAS RETRIEVED VIA SNARE. A NEW 5-4MM AMPLATZER DUCT OCCLUDER II WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180779 ↗
• DeathMay 27, 2021Migration or Expulsion of Device; Off-Label Use; Migration or Expulsion of Device; Off-Label Use

  THIS REPORT IS BEING CONSERVATIVELY REPORTED DESPITE THE PATIENTS DECLINING PROGNOSIS AND LACK OF VIABLE THERAPEUTIC OPTIONS AS REPORTED BY THE IMPLANTING PHYSICIAN. ALL EFFECTIVE TREATMENT OPTIONS WERE EXHAUSTED. SURGICAL INTERVENTION WAS A FINAL ATTEMPT DESPITE THE PATIENT NOT BEING A CANDIDATE FOR SURGERY. ON (B)(6) 2021, A PATIENT WITH A BAD DIAGNOSIS AND SUFFERING FROM HEMODYNAMIC SHOCK, RENAL FAILURE AND AN IMPAIRED LIVER RAN OUT OF EFFECTIVE TREATMENT OPTIONS. AS A RESULT, SURGERY WAS PERFORMED AND THE PATIENT WAS PLACED ON PULMONARY VENTILATION TO HELP THEM ENDURE THE PROCEDURE. A 5/2 AMPLATZER PICCOLO OCCLUDER WAS SELECTED FOR IMPLANT IN A PATENT DUCTUS ARTERIOSUS (PDA) WITH THE FOLLOWING DIMENSIONS: PDA LENGTH OF 6-7 MM AND DIAMETER AT AORTIC AMPULLA OF 4.8. DURING THE IMPLANT PROCEDURE, THE DEVICE WAS MIS-SIZED AND FOUND TO BE OCCLUSIVE ON THE LEFT PULMONARY ARTERY RESULTING IN CARDIOGENIC BLOCK. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS ATTEMPTED. A 6 MM AMPLATZER VASCULAR PLUG II (AVP2) WAS THEN USED, DESPITE NOT BEING A SUITABLE SIZE FOR THE PDA. AGAIN THE DEVICE WAS MIS-SIZED AS IT WASN'T ABLE ADAPT TO THE SIZE OF THE PDA. THE AVP2 AND THE SHEATH WERE REMOVED. A

  Patient problems: Cardiac Arrest; Foreign Body Embolism

  MAUDE report 11894434 ↗
• InjuryApr 21, 2020Connection Problem; Connection Problem

  ON (B)(6) 2020, A 6MM AMPLATZER VASCULAR PLUG II WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, THE DEVICE PREMATURELY DETACHED IN THE SVC AND WAS SNARED. A NEW UNKNOWN SIZED, UNKNOWN DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IS NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9982552 ↗
• InjuryMar 6, 2019Migration; Migration

  RELATED MANUFACTURER NUMBER: 2135147-2019-00063. ON AN UNKNOWN DATE, AN 4 AMPLATZER VASCULAR PLUG II SELECTED FOR IMPLANT. THE DEVICE WAS DEPLOYED, BUT MIGRATED AFTER DEPLOYMENT. AN 6MM AMPLATZER VASCULAR PLUG II WAS THEN SELECTED BUT THAT DEVICE ALSO MIGRATED. AN 8MM AMPLATZER VASCULAR PLUG II WAS THEN SUCCESSFULLY IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8397528 ↗