MAUDE Adverse Event Report: ST. JUDE MEDICAL COSTA RICA LTDA. AMULET; TRANSCATHETER SEPTAL OCCLUDER

Lot Number 8128562

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 01/05/2022

Event Type  Death  

Event Description

Ablation was done (b)(6) 2022.Implant of amulet done (b)(6) 2022.No post op teaching of taking frequent bp or pulse ox after discharge.Patient arrested on (b)(6) 2022 due to a cardiac tamponade caused by a puncture to heart tissue during ablation or amulet implant and died on (b)(6) 2022.The amulet manufacturer was st jude, sz 28 mm, lot 8128562.Multiple agencies and physicians have been informed but the only response has been from (b)(6) saying they will do a record review.Family isn't asking for $ or suing - but there are many lives that could be saved by adding these simple instructions to post op teaching and no one is willing to listen! the companies patient booklets don't contain any instructions for this type of monitoring yet the study published in the american journal of cardiology on watchman complication revealed pericardial effusion most frequently reported ae.The amulet is similar to the watchman in purpose.Just asking for simple additional post op instructions and no one is listening.Fda safety report id # (b)(4).

• Brand Name: AMULET
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL COSTA RICA LTDA.
• MDR Report Key: 14976407
• MDR Text Key: 295685399
• Report Number: MW5110771
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: 8128562
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Death
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White