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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS

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ABBOTT MEDICAL AMPLATZER TORQVUE DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-ITV09F45/80
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)
Event Date 06/04/2021
Event Type  Death  
Manufacturer Narrative

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

 
Event Description

It was reported that a 14mm amplatzer muscular ventricular septal defect (vsd occluder was selected for implant using a 9f amplatzer torqvue delivery system for a high risk, post myocardial infraction (mi) vsd closure on (b)(6) 2021. The (b)(6) year old patient had a vsd that was measured via computerized tomography (ct), transesophageal echocardiogram (tee), and left ventricular (lv) angiography. The defect measurement was about 10-11mm. The delivery system was placed in the internal jugular (ij) access site. Prior to deployment, a small pericardial effusion and a drop in the patient's pressures were observed on echocardiogram (echo). The device was attempted to be placed, however was deemed too small. The patient developed tamponade and the occluder was re-sheathed and removed from the patient. Pericardiocentesis was performed. It was believed that the pericardial effusion occurred while gaining access and crossing the defect. The patient's rhythm changed and became unstable. It was noted that the patient was shocked several times. An 18mm amplatzer post-infarct muscular vsd occluder was then attempted to be implanted using the same delivery system and placed appropriately within the defect; confirmed by tee. The patient continued to code for one hour and was declared deceased. The 18mm device was never released from the cable and not implanted. It was noted that the physician did not believe death was related to the vsd devices, instead suspected tamponade was caused by cardiac perforation prior to device deployment. No additional information was provided.

 
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Brand NameAMPLATZER TORQVUE DELIVERY SYSTEM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key12088476
MDR Text Key260020656
Report Number2135147-2021-00266
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK072313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/12/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/29/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ITV09F45/80
Device Catalogue Number9-ITV09F45/80
Device LOT Number7655678
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/09/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/29/2021 Patient Sequence Number: 1
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