MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE DELIVERY SYSTEM; CATHETER, PERCUTANEOUS

Model Number 9-ITV10F45/80

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

Patient Problems Death (1802); Myocardial Infarction (1969); Renal Failure (2041)

Event Date 11/01/2018

Event Type  Death  

Event Description

An attempt was made to close a large post infarct vsd at the apex/rv free wall in an (b)(6) female patient, who was on balloon pump and in renal failure.The plan was to try and close the vsd with the largest device; however, the tissue around the defect was very poor.The user created an av loop and passed through the defect with a 10f amplatzer torqvue delivery system.Before the user was able to implant a device the rv free wall gave way and ruptured and the patient passed away on the table.The user does not believe the delivery system caused the rupture, as it was friable tissue.

Manufacturer Narrative

An event of patient death following a rupture in the rv free wall was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined; however, information from the field indicated that "the user does not believe the delivery system caused the rupture, as it was friable tissue." the patient was (b)(6) years old and on balloon pump and in renal failure.

Event Description

An attempt was made to close a large post infarct vsd at the apex/rv free wall in an (b)(6)-year-old female patient, who was on a balloon pump and in renal failure.The plan was to attempt to close the vsd with the largest device; however, the tissue around the defect was very poor and friable.The user created an av loop and passed through the defect with a 10f amplatzer torqvue delivery system, however; before the user was able to implant a device the rv free wall gave way and ruptured and the patient passed away on the table.The user does not believe the delivery system caused the rupture, as the rv was friable following the infarct.

• Brand Name: AMPLATZER TORQVUE DELIVERY SYSTEM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8063852
• MDR Text Key: 126915680
• Report Number: 2135147-2018-00209
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ITV10F45/80
• Device Catalogue Number: 9-ITV10F45/80
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR