MAUDE Adverse Event Report: ABBOTT MEDICAL; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-VSDMPIHDE-022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Cardiogenic Shock (2262); Liver Failure (4492)

Event Date 02/04/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

This event is being conservatively reported as the implant of the amplatzer post-infarct muscular ventricular septal defect (vsd) occluder was reported as an emergency use of the device because the vsd was life-threatening and required immediate use.It was reported that on (b)(6) 2020, the patient had a myocardial infarct (mi).The patient underwent a amplatzer post-infarct muscular ventricular septal defect (vsd) occluder implant procedure on (b)(6) 2020 due to inferior st-segment elevation myocardial infarction (stemi) and ventricular septal defect.The patient had an echocardiogram (echo) on (b)(6) 2020, and the vsd occluder appeared well-seated with some residual color flow anterior to the device.On (b)(6) 2020, a repeat echo was performed that indicated a small amount of left to right flow involving the distal and proximal edge of the device.A right cardiac catheterization was performed on (b)(6) 2020 reflecting a hemodynamically significant residual left to right shunt.On (b)(6) 2020, the patient developed flash pulmonary edema, congestive heart failure (chf), and cardiogenic shock, requiring re-intubation and intra-aortic balloon pump (iabp) for hemodynamic support.The large vsd was surgically closed with 2 surgical biologic patch.It was noted that a small vsd remained at the end of the case, located inferoseptal along the basal/mid-papillary region.No further surgical procedures could be performed regarding the vsd.The patient was moved to palliative care.The patient had a fever, pulmonary infiltrates and hypotension that lead to a shock liver and subsequent dehiscence of the vsd occluder seen on tee on (b)(6) 2020.The patient passed away on (b)(6) 2020.The patient's death certificate states the cause of death was due to acute ischemic ventricular septal defect.It was noted that the physician did not allege a malfunction with the vsd occluder.

Manufacturer Narrative

An event of fever, pulmonary infiltrates and hypotension that lead to a shock liver and death due to acute ischemic was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12071811
• MDR Text Key: 258524103
• Report Number: 2135147-2021-00248
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: H070005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-VSDMPIHDE-022
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 91