Amplatzer™ Vascular Plug 4 (REF 9-AVP038-006)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811806012360), received between Jun 16, 2023 and Dec 5, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Fold, Unfold or Collapse” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268497 ↗
• InjuryJun 16, 2023Difficult to Fold, Unfold or Collapse; Fracture; Improper or Incorrect Procedure or Method; Separation Problem; Difficult to Fold, Unfold or Collapse; Fracture; Improper or Incorrect Procedure or Method; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 6MM AMPLATZER VASCULAR PLUG IV WAS SELECTED FOR AN IMPLANT. DURING THE PROCEDURE, THERE WAS ISSUE WITH THE PLUG. IT WAS IMPOSSIBLE TO DETACH THE PLUG AND IMPOSSIBLE TO RETRACT THE PLUG AFTER DEPLOYMENT IN THE LEFT GONADAL VEIN. THE DELIVERY WIRE WAS LEFT IN PLACE (LEFT GONADAL VEIN, LEFT RENAL VEIN, LEFT CAVE VEIN, RIGHT ILIAC VEIN AND RIGHT COMMON FEMORAL VEIN) AND SECURED IN THE RIGHT ILIAC VEIN WITH A STENT TO LIMIT RISK OF SECONDARY MIGRATION. THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY. THE PLUG WAS NOT DEFORMED/DAMAGED/ DURING PROCEDURE. AN ANTIAGGREGANT TREATMENT WILL BE APPLIED TO THE PATIENT FOR 6 MONTHS POST PROCEDURE TO LIMIT THE RISK OF VENOUS THROMBOSIS AT THE RENAL VEIN, RISK OF COMPLICATION AT THE LOWER MEMBER, RISK OF MIGRATION IN THE HEART. THE PROCEDURE TIME WAS EXTENDED TO A TOTAL TIME OF 3 HOURS. PATIENT STATUS WAS REPORTED AS STABLE. NO ADDITIONAL INFORMATION PROVIDED. ON 18 AUGUST 2023, ADDITIONAL INFORMATION RECEIVED; THE PLUG REMAINED IMPLANTED AT THE TARGET LESION AND REMAINED ATTACHED TO THE DISTAL PART OF THE CABLE. PART OF THE CABLE WITH THE PLUG AND LEFT IN THE PATIENT. THE CABLE IS MAINTAINED BY THE PLUG DISTALLY

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17148744 ↗