MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-PFO-018
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020 an amplatzer occluder was implanted in a (b)(6) female.Pulmonary embolism was found as patient was being evaluated for stroke at hospital.No information for shunt during discharge.During follow up - no symptom of stroke when the patient was interviewed.At 12 month (in june), tee showed mild residula shunt, but no thrombus.Surgical intervention was performed for the stroke, pulmonary embolism, and deep vein thrombosis.Ventilator dependent respiratory failure on (b)(6) 2020, left anterior fascicular block septal myocardial infarction.Patient was admitted for stroke and pulmonary embolism and dvt.Surgical intervention was performed.
Additional Manufacturer Narrative
An event of pulmonary embolism about one year after pfo device implantation, along with residual shunt, stroke, and deep vein thrombosis was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER PFO OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10471329
• Report Number: 2135147-2020-00383
• Device Sequence Number: 13993283
• Product Code: MLV
• UDI-Device Identifier: 00811806011271
• UDI-Public: 00811806011271
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 9-PFO-018
• Device Catalogue Number: 9-PFO-018
• Device Lot Number: 6808958
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/31/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR