MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER® TORQVUE® (UNKNOWN); CATHETER, PERCUTANEOUS

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

Patient Problem Tricuspid Regurgitation (2112)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, out of 64 patients implanted with an amplatzer piccolo device two patients had complications related to the implant procedure, with mild tricuspid valve trauma occurring due to the catheter.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Reference manufacturing report number 2135147-2020-00163.It was reported through a research article identifying amplatzer duct occluder ii that may be related to a complications post procedure.Details are listed in the article, titled "improved ventilation in premature babies after transcatheter versus surgical closure of patent ductus arteriosus" it was reported in the article that 64 patients had a patent ductus arteriosus closure from 2016 to 2018.The patient had a weight range from 800 to 2,900 grams.Post procedure, there were 13 complications.Two patients experienced mild tricuspid valve catheter-related trauma, with mild regurgitation.

• Brand Name: AMPLATZER® TORQVUE® (UNKNOWN)
• 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: 9981647
• MDR Text Key: 188902851
• Report Number: 2135147-2020-00162
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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: 03/24/2020
• 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
• Patient Outcome(s): Other; Required Intervention