MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TORQVUE 45X45 DELIVERY SHEATH; DELIVERY SYSTEM

Model Number 9-TV45X45-14F-100

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 05/15/2017

Event Type  Death  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with abbott specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

A patient with a history of multiple co-morbidities including a stroke in 2015, existing icd, diabetes, nyha iii/iv classification, and gi bleed resulting in haemorrhagic shock 5 weeks prior to procedure was prepped for laa closure procedure.After placement of the 14f amplatzer torqvue 45 x 45 delivery sheath, the patient's blood pressure dropped and cpr was initiated.Following 90 minutes of resuscitative measures, the patient did not respond and was pronounced dead.Per report, the cause of death was irreversible heart failure and was not reported to be device-related.

• Brand Name: AMPLATZER TORQVUE 45X45 DELIVERY SHEATH
• Type of Device: DELIVERY SYSTEM
• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6614531
• MDR Text Key: 76748367
• Report Number: 2135147-2017-00059
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K120120
• 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
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 9-TV45X45-14F-100
• Device Catalogue Number: 9-TV45X45-14F-100
• Device Lot Number: 5694351
• Other Device ID Number: 00811806014111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2016
• 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): Required Intervention
• Patient Age: 71 YR