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

Model Number 9-TVLPC4F90/080

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

Patient Problem Tricuspid Regurgitation (2112)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2020, a 5-2 amplatzer piccolo was selected for implant for a (b)(6) kg premature infant.The device was placed and released, and the delivery cable and catheter were removed from the patient.Further imaging via tte (transthoracic echocardiography) noted that the device was stable and in good position.It was then noted that there was a moderate to severe tricuspid valve regurgitation that was not present pre-procedure and that a there was a flailed tricuspid valve leaflet.It was noted by the physician that this injury to the tv likely occured while the delivery system was in the patient as the ds was crossed into the tricuspid valve and into the pa across the pda to deliver the device.The patient was watched in the cardiac cath lab for an additional hour.The decision was made to transport the patient back to the nicu and monitor the patient closely.

Manufacturer Narrative

Additional information for: g4, g7, h2, h6, and h10.The delivery system for the implanted device was not returned, and therefore a physical analysis related to the reported experience could not be completed.The occluder device remained implanted.The serial number was not reported so the analysis of a device from a common or adjacent manufacturing lot could not be completed.

• Brand Name: AMPLATZER TORQVUE LP CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10048152
• MDR Text Key: 190699211
• Report Number: 2135147-2020-00204
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K162228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 05/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-TVLPC4F90/080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 MO
• Patient Weight: 1