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

Model Number	9-ASD-MF-035
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2020, a 30mm amplatzer cribriform occluder was selected for implant using an amplatzer torqvue delivery system (9-itv10f45/80).During the procedure the device could not catch the aortic rim as the direction of the disc was perpendicular to the aortic rim, so the physician adjusted the direction of the delivery system and re-deployed the device.Upon deployment both the la and ra discs formed a doughnut shape.The device was re-sheathed and removed from the patient.The physician deployed the device outside the patient and again the discs formed a doughnut shape.The physician decided to upsize to a 35mm amplatzer cribriform occluder because the 30mm device did not seem big enough.Using the 10f delivery system, the first deployment was unsuccessful, during the second attempt the discs formed a doughnut shape again, but after the wiggle test the disc became acceptable.The 35mm amplatzer cribriform occluder was successfully implanted.The patient remained stable throughout the procedure and there was no clinically significant delay in the procedure.Reference manufacturing report number 2135147-2020-00147.
Additional Manufacturer Narrative
Additional information for: g4, g7, h2, h6, and h10.An event of the device deploying deformed initially and an "unsuccessful" first deployment was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis; however, two photos were received for analysis.Based solely on the aforementioned photos, the device appeared to initially deploy in a bulbous conformation inside the patient.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Though the occluder reconformed to the correct shape during the procedure, initial deformity upon deployment was further investigated and no root cause was definitively established.However, a resolution plan aimed at addressing enhanced loading techniques as well as and an improved in-process inspection that better represents how a device is loaded and deployed during clinical use are being implemented.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9960250
• Report Number: 2135147-2020-00148
• Device Sequence Number: 14057474
• Product Code: MLV
• UDI-Device Identifier: 00811806010311
• UDI-Public: 00811806010311
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 9-ASD-MF-035
• Device Catalogue Number: 9-ASD-MF-035
• Device Lot Number: 5794028
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER CRIBRIFORM OCCLUDER (9-ASD-MF-030).
• Outcome Attributed to Adverse Event: Required Intervention