Amplatzer™ 9-AVP2-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00811806010434), received between Mar 14, 2019 and Mar 24, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2021Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  ON (B)(6) 2021, A 20MM AMPLATZER VASCULAR PLUG II WAS IMPLANTED. DURING RADIOGRAPHIC CONTROL THE PHYSICIAN OBSERVED THAT THE PLUG HAD MIGRATED TO THE LEFT PULMONARY ARTERY. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE PLUG WITH A COOK ANGIOGRAPHY CATHETER HOWEVER, THE TIP SEPARATED AND THE PLUG AND DISTAL CATHETER COULD NOT RETRIEVED AND REMAINED IN THE PATIENT. ON (B)(6) 2021, A THORACOTOMY AND ARTERIOTOMY WAS PERFORMED TO RETRIEVE THE PLUS AND THE CATHETER TIP. THE DEVICE WAS ENTRAPPED IN THE PULMONARY ARTERY WHICH WAS RESPONSIBLE FOR A THROMBOSIS OF THE ATRIAL BRANCHES AT THE INFERIOR LEFT LUNG. THE PATIENT WAS PUT ON ANTICOAGULANT TREATMENT FOR THE NEXT 3 MONTHS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11561889 ↗
• InjurySep 16, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  ON (B)(6) 2020, A 20MM AMPLATZER VASCULAR PLUG II (AVPII) WAS SELECTED FOR IMPLANT. AFTER RELEASED, THE DEVICE WAS OBSERVED TO HAVE JUMPED INTO THE INNOMINATE VEIN. THE AVPII WAS SNARED AND REMOVED FROM THE PATIENT. ULTIMATELY, NO DEVICE WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10541087 ↗
• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FOR AN EVENT INITIALLY REPORTED UNDER RELATED MANUFACTURER REPORT NUMBER: 2135147-2016-00100. ACCORDING TO THE ARTICLE "PULMONARY ARTERIAL HYPERTENSION ASSOCIATED WITH CONGENITAL PORTOSYSTEMIC SHUNTS TREATED WITH TRANSCATHETER EMBOLIZATION AND PULMONARY VASODILATORS" (DOI: 10.2169/INTERNALMEDICINE.55.6557), A PATIENT IMPLANTED WITH A 20MM AMPLATZER VASCULAR PLUG II (AVPII) SECONDARY TO AN INTRAPULMONARY SHUNT REPORTED DYSPNEA AND WAS DIAGNOSED WITH HEPATOPULMONARY SYNDROME AND PORTOPULMONARY HYPERTENSION CAUSED BY CONGENITAL PORTOSYSTEMIC SHUNTS. APPROXIMATELY THREE MONTHS POST-IMPLANT, THE PATIENT'S SYMPTOMS WORSENED REPORTEDLY INDICATING THAT TRANSCATHETER EMBOLIZATION EXACERBATED HER PULMONARY ARTERIAL HYPERTENSION. THE PATIENT WAS PLACED ON VASODILATOR THERAPY. SIX MONTHS LATER, HYPOXIA REMAINED AND AN IMPROVEMENT IN SYMPTOMS WAS NOTED. CLINICAL SITE PATIENT ID: (B)(6).

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 8423284 ↗