Amplatzer™ TorqVue™ 9-TV2-07F120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811806012551), received between Jul 1, 2022 and Jul 20, 2022 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Difficult to Advance” (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 18, 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.

• DeathJul 20, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT ON (B)(6) 2022, AN AMPLATZER VALVULAR PLUG 3 AND A 7F AMPLATZER TORQVUE 2 (TV2) DELIVERY SHEATH WERE SELECTED FOR PROCEDURE TO CLOSE A SEPTAL PARAVALVULAR LEAK (PVL) IN A PREVIOUSLY IMPLANTED NON-ABBOTT MECHANICAL MITRAL VALVE. AN ANTEGRADE APPROACH WAS USED VIA TRANSSEPTAL PUNCTURE. REPORTEDLY, THE 7F TV2 DELIVERY SHEATH WAS UNABLE TO BE ADVANCED SUCCESSFULLY, AND THE LEAK WAS DIFFICULT TO REACH USING A NON-ABBOTT INTRODUCER AND NON-ABBOTT GUIDEWIRE. THE DECISION WAS MADE TO REPLACE THE 7F TV2 DELIVERY SHEATH WITH ANOTHER 6F AMPLATZER TORQVUE 2 (TV2) DELIVERY SHEATH OVER THE WIRE. THE 6F TV2 DELIVERY SHEATH WAS ALSO DIFFICULT TO ADVANCE. THE PATIENT'S BLOOD PRESSURE AND OXYGEN DROPPED. PERICARDIAL EFFUSION OCCURRED, AND THE PATIENT FLATLINED. REANIMATION WAS ATTEMPTED, BUT ULTIMATELY THE PATIENT PASSED AWAY. THERE WAS NO KINK OR ANGULATION NOTED IN EITHER THE 7F TV2 OR THE 6F TV2, AND PATIENT WAS NOT REPORTED TO HAVE TORTUOUS ANATOMY. THE HEMOSTASIS VALVE WAS USED FOR BOTH THE 7F TV2 AND THE 6F TV2. THE CAUSE OF THE PERICARDIAL EFFUSION WAS UNKNOWN, THERE WAS DIFFICULTY WITH ADVANCING ALL MENTIONED DEVICES THROUGH THE PATIENT'S ANATOMY. THEREFORE THIS EVENT IS

  Patient problems: Pericardial Effusion

  MAUDE report 15063426 ↗
• InjuryJul 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT AN AMPLATZER VALVULAR PLUG III 12MM X 5M WAS IMPLANTED ON (B)(6) 2022., POST PROCEDURE, BUT PRIOR TO DISCHARGE FROM HOSPITAL, ACUTE RIGHT LIMB ISCHEMIA WITH RIGHT COMMON FEMORAL OCCLUSION DUE TO RIGHT FEMORAL ARTERY DISSECTION WITH THROMBUS FORMATION WAS OBSERVED AND WAS TREATED WITH RIGHT ILIOFEMORAL ENDARTERECTOMY WITH BOVINE PATCH WITH IMPROVEMENT OF SYMPTOMS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14892286 ↗