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

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

Patient Problems Perforation (2001); Tricuspid Regurgitation (2112)

Event Date 09/19/2018

Event Type  Injury  

Manufacturer Narrative

An event of damage to the tricuspid valve was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Reference manufacturing report 2135147-2020-00217.On (b)(6) 2018, a 5x2mm amplatzer duct occluder ii additional sizes was implanted in the pulmonary position.The patient was (b)(6) days old, (b)(6) grams on date of implant.The pda dimension was the following by echocardiography: minimal ductal diameter: 3mm, maximum ductal diameter: 3.9mm, length: 11.4mm, placement and initial echocardiogram revealed the device was well placed.On (b)(6) 2018, valve damage was observed with severe regurgitation and leaflet perforation of the tricuspid valve.On (b)(6) 2018, the device had migrated toward the pulmonary artery and was partly in mpa, with a large degree of left to right low velocity patent ductus.The patient was brought back to the cath lab and the occluder was explanted without any complications.On (b)(6) 2018, echocardiogram showed the pda had decreased in size and was almost not viewable.The patient is reported to be stable will continue to be monitored.

• Brand Name: AMPLATZER® TORQVUE® LP 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: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10073307
• MDR Text Key: 191567674
• Report Number: 2135147-2020-00217
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2020
• 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
• Treatment: AMPLATZER ADOII AS 5X2MM IDE LONG PKG ST
• Patient Outcome(s): Required Intervention
• Patient Age: 76 DA
• Patient Weight: 1