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

Model Number 9-ASD-MF-025

Device Problem Material Deformation (2976)

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

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020 a 25 mm amplatzer cribriform occluder was chosen for a pfo closure procedure.While the implanting physician was attempting the closure, the physician called abbott rep, as the abbott rep was not notified prior.Although the device was not released the abbott rep was called via (b)(6) after its deployment to help ascertain the cause of the left atrial disc becoming misshaped.The physician explained the events as they occurred during before and during deployment.The abbott rep stated that it was difficult to ascertain the cause remotely after device deployment.Based on limited information available, the abbott rep suggested the recapture and retrieval of the 25mm device.The device was recaptured and retrieved without issue.After retrieving the device, the physician examined if device was in fact deformed.The physician confirmed that the left atrial disc was not returning to its proper shape.A new device was recommended, and physician chose to upsize to a 30mm cribiform device, the same deformation occurred.It was at this time the physician chose to remove the device and abort the procedure.The patient remained stable throughout the procedure per the physician.Physician stated that the patient was not impacted.Devices: 25mm cribiform occluder: ref: 9-asd-mf-025, lot 6840860.30mm cribiform occluder: ref: 9-asd-mf-030, lot: 553314.

Manufacturer Narrative

Correction: b5 additional information: d10,g4,h2,h3,h6,h10.The reported event of a deformed, bulbous deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing 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.

Event Description

On (b)(6) 2020 a 25 mm amplatzer cribriform occluder was chosen for a pfo closure procedure.While the implanting physican was attempting the closure, the physician called abbott rep, as the abbott rep was not notified prior.Although the device was not released the abbott rep was called via facetime after its deployment to help ascertain the cause of the left atrial disc becoming mishaped.The physician explained the events as they occurred during before and during deployment.The abbott rep stated that it was difficult to ascertain the cause remotely after device deployment.Based on limited information available, the abbott rep suggested the recapture and retrieval of the 25mm device.The device was recaptured and retireved without issue.After retrieving the device, the physician examined if device was in fact deformed.The physician confirmed that the left atrial disc was not returning to its proper shape.A new device was recommended, after attempting with 25mm x2, the physician chose to upsize to a 30mm cribiform device, the same deformation occurred.It was at this time the physician chose to remove the device and abort the procedure.The patient remained stable throughout the procedure per the physician.Physician stated that the patient was not impacted.Devices: 25mm cribiform occluder ref: 9-asd-mf-025 lot 6840860; 9-asd-mf-025 lot: 6928439, 30mm cribiform occluder ref: 9-asd-mf-030 lot: 553314.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10270967
• MDR Text Key: 199824312
• Report Number: 2135147-2020-00305
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: 00811806010298
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 6840860
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention