MAUDE Adverse Event Report: ABBOTT LABORATORIES / ST. JUDE MEDICAL AMPLATZER SAPTAL OCCLUDER (26MM); TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-ASD-026

Device Problem Material Erosion (1214)

Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombus (2101); Collapse (2416); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/12/2018

Event Type  Injury  

Event Description

Erosion of 26mm amplatzer septal occluder 17 months after placement.Erosion resulted in an acute hemopericardium, hypotension and collapse.Emergent pericardiocentesis and surgical repair ensued.A (b)(6) boy with a large 2" asd (22-24mm by tee) that underwent device closure with a 26mm amplatzer septal occluder on (b)(6) 2017 without incident.He was discharged home the following morning with the device in excellent position and no pericardial effusion.He was seen in the office twice since then with normal "tee's".On (b)(6) 2018 he collapsed on his bathroom floor and had to be emergently transported to the er.In retrospect, he had been complaining of chest discomfort for about 1 week.After an echo showed a large pericardial effusion, he had an emergent pericardiocentesis with blood (300cc) evacuated.He immediately had an increase in bp from 70/40 to 130/80 and hr decreased.He was then brought to the operating room where a 6 x 3mm perforation was found in the dome of the la and a 2 x 3mm perforation in the non-coronary sinus.These were repaired, the device was removed and a pericardial patch closure was performed.He recovered uneventfully although had to be taken back to operating room to remove a large clot that was in the pericardium and compressing the la.No neurologic injury was sustained.

• Brand Name: AMPLATZER SAPTAL OCCLUDER (26MM)
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT LABORATORIES / ST. JUDE MEDICAL
• MDR Report Key: 8160243
• MDR Text Key: 130469973
• Report Number: MW5082067
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 5275310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 55