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

Model Number PFO OCCLUDER

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020 a 25mm amplatzer pfo occluder was implanted.On (b)(6) 2020 the patient became hypotensive post procedure.The patient complained of abdominal pain.In stat ct acute hemorrhage was observed.The patient was taken for an emergent repair of common femoral vein injury and inferior epigastric artery.The patient was reported to be in stable condition.

Manufacturer Narrative

Correction: d2, h1 additional information: g4, h2, h6, h10 an event of abdominal pain, acute hemorrhage, femoral vein injury, and inferior epigastric artery injury was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TORQVUE (UNKNOWN)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10845784
• MDR Text Key: 217107204
• Report Number: 2135147-2020-00488
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR