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

Model Number 9-PFO-030

Device Problem Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 30mm amplatzer pfo occluder (7221961) was selected for implant.While deploying the occluder a bulbus deformation was noted.The occluder was removed and replaced with another 30mm amplatzer pfo occluder (7224657).During deployment a bulbus deformation was noted.The second occluder was removed and replaced with a 25mm amplatzer cribriform occluder which was successfully implanted.The patient was reported to be in stable condition.Manufacturer report number: 2135147-2020-00345.

Manufacturer Narrative

Additional information: h6.An event of device deformity upon deployment was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis; however, 3 photos were received for analysis.Based solely on the aforementioned photos, the device did appear to deploy deformed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10338141
• MDR Text Key: 201018285
• Report Number: 2135147-2020-00346
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9-PFO-030
• Device Lot Number: 7221961
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/29/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 08/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9-PFO-030, 7224657
• Patient Outcome(s): Required Intervention