AMPLATZER™ 9-TV45X45-14F-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811806014111), received between Jan 25, 2019 and Sep 29, 2021 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2021Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT WITH CORONARY HEART DISEASE AND CARDIOMYOPATHY WAS ADMITTED TO THE HEMODYNAMIC ROOM TO PERFORM AN APPLICATION CLOSURE WITH AMPLATZER DEVICE. DURING THE SURGERY, THE PATIENT WAS SEDATED, INTUBATED, AND HAD THEIR ACCESS SITE PREPPED. THE ACCESS PUNCTURE WAS PERFORMED USING AN INTRODUCER WITH A NEEDLE AND GUIDE. ONCE THE SHEATH WAS PLACED IN THE ATRIAL APPENDAGE, THE GUIDEWIRE WAS CHANGED FOR ONE WITH HIGHER SUPPORT AND THEN CONTINUED WITH PREPARING THE LOADING SYSTEM. ALL THIS PROCESS WAS PERFORMED BY THE DOCTOR. THE VEIN WAS THEN PRE-DILATED AND THE SHEATH WAS INTRODUCED. AFTER BEING ADVANCED 3-4 CM, THE DILATOR TIP ENDED UP FRACTURING. THE SHEATH WAS REMOVED, BUT THE FRACTURED PART OF THE DILATOR TIP REMAINED IN THE VESSEL. AFTER THIS, A DISSECTION HAD TO BE MADE TO BE ABLE TO EXTRACT THE FRACTURED PIECE. THE PATIENT STARTED TO BECOME HYPOTENSIVE AND DESATURATE DUE TO BLOOD LOSS. IT TOOK A LONG TIME TO REMOVE THE TIP OF THE SHEATH SO IT WAS DECIDED TO SUSPEND THE CLOSURE OF THE ATRIAL APPENDAGE. THE PATIENT HAD TO BE TRANSFUSED AND WENT TO AN INTUBATED INTENSIVE CARE UNIT (ICU). PATIENT IS STABLE.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Vascular Dissection

  MAUDE report 12547876 ↗
• DeathJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A 31MM AMPLATZER AMULET WAS IMPLANTED. ON (B)(6) 2017, A TEE REVEALED A SMALL PERICARDIAL EFFUSION AND WAS DEEMED NOT CLINICALLY SIGNIFICANT. NO INTERVENTION WAS PERFORMED. ON (B)(6) 2017, THE PATIENT WAS REPORTED TO HAVE EXPIRED. OF NOTE, THE DEATH WAS NOT RELATED TO THE IMPLANT DEVICE OR PROCEDURE. (CLINICAL STUDY PATIENT ID: (B)(6)).

  Patient problems: Death; Pericardial Effusion

  MAUDE report 8696972 ↗
• InjuryMar 25, 2019Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2019, A 14F AMPLATZER TORQVUE SHEATH WAS USED TO IMPLANT AN AMPLATZER AMULET. AFTER INSERTING THE 14F SHEATH IN THE VENA CAVA INFERIOR, RESISTANCE WAS ENCOUNTERED AND THE SHEATH KINKED. THE USER ATTEMPTED TO STRAIGHTEN AND MANIPULATE THE SHEATH WITHIN THE PATIENT TO NO SUCCESS. ANOTHER 14F AMPLATZER TORQVUE SHEATH WAS SELECTED AND THIS NEW SHEATH KINKED AS WELL. A 10F LAMBRE SHEATH WAS SELECTED WHICH WAS ABLE TO TRAVERSE THE PATIENT'S ANATOMY, HOWEVER, THE LAMBRE LAAO DEVICE WAS UNABLE TO BE IMPLANTED. THE PROCEDURE WAS ABORTED AS 320ML OF CONTRAST HAD BEEN USED AND A FUTURE PROCEDURE IS SCHEDULED. NO PATIENT CONSEQUENCES WERE REPORTED. THE PATIENT HAD HIGHLY TORTUOUS ANATOMY OF THE FEMORAL ARTERY, AND INSERTION THROUGH THE TRANSSEPTAL PUNCTURE WAS DIFFICULT DUE TO 4 PREVIOUS PUNCTURES FOR ABLATION PROCEDURES. THE USER PLANS TO USE A BALLOON IN THE SEPTUM AND TO IMPLANT AN AMPLATZER AMULET.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8448112 ↗
• InjuryJan 25, 2019Retraction Problem; Material Deformation; Material Twisted/Bent; Retraction Problem; Material Deformation; Material Twisted/Bent

  ON (B)(6) 2019, AN AMPLATZER AMULET (SIZE UNKNOWN) WAS SELECTED FOR IMPLANT USING A 14F AMPLATZER DELIVERY SHEATH. DURING POSITIONING, THE OCCLUDER WAS PARTIALLY RETRACTED AND DEPLOYED TWO TIMES; HOWEVER, THE FINAL POSITION WAS NOT OPTIMAL FOR RELEASE AND THE USER INTENDED TO EXCHANGE THE AMULET FOR A SMALLER DEVICE. WHILE COMPLETELY RE-SHEATHING THE OCCLUDER, THE SHEATH TIP WAS REPORTED TO BE "WRIGGLED INSIDE". THE USER APPLIED ADDITIONAL FORCE TO RETRIEVE THE DEVICE WHICH RESULTED IN SHEATH DEFORMATION AND DISTORTION. A CORONARY BALLOON WAS INSERTED OVER THE GUIDE WIRE TO INFLATE AND EXPAND THE SHEATH TIP, WHICH ALLOWED THE AMULET TO BE PARTIALLY RETRACTED, BUT A FULL RE-SHEATH WAS NOT POSSIBLE. THE USER ELECTED TO REMOVE THE DILATOR AND CUT ITS TIP THEN RE-INSERT IT OVER THE GUIDE WIRE. ANOTHER ATTEMPT WAS MADE TO RE-SHEATH THE DEVICE WHICH RESULTED IN THE DELIVERY CABLE TO BREAK APART AT THE "STIFF AND FLOPPY SEGMENT" JUNCTION. THE AMULET WAS NO LONGER CONNECTED TO THE DELIVERY CABLE AND THE SYSTEM WAS REMOVED FROM THE PATIENT. DESPITE ONLY BEING PARTIALLY RE-SHEATHED, THE AMULET REMAINED INSIDE THE LUMEN OF THE SHEATH AND WAS REMOVED. NO ADDITIONAL ATTEMPTS WERE MADE TO DELIVE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8277382 ↗