MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER P.I. MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-VSDMPIHDE-024
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
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, given all of the measurements from the echo and ct studies a 24mm pivsd occluder was selected for implant using a 10fr trevisio delivery system in a (b)(6) year old patient with a post infarct vsd.After placing the device, the right ventricular disc appeared to be constrained in an unusual configuration by some trabeculations.Multiple attempts were made to recapture and reposition the device, but the right ventricular disc was unable to get in a good position.The device was removed from the patient and it was noted that the device was distorted and could not be re-shaped.A new 24 mm pivsd occluder was selected for implant.Once placed in the septum, the device yielded the same elongated and constrained configuration as the previous device.The physician determined that the patient had a long serpiginous tract and decided to use a 35mm amplatzer cribriform occluder.The 35mm device was successfully implanted in the patient.The patient remained stable throughout the procedure and there was no clinically significant delay in the procedure.Follow-up echo after the procedure showed that the device was in good position.The patient is recovering.Reference manufacturing report number 2135147-2020-00155.
Additional Manufacturer Narrative
An event of the device appearing constrained by some trabeculations upon deployment, inability to get the device in a good position, and the device being distorted and unable to be reshaped was reported.The investigation confirmed the device met visual and 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 specifications.The cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER P.I. MUSCULAR VSD OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9970118
• Report Number: 2135147-2020-00156
• Device Sequence Number: 16886283
• Product Code: MLV
• UDI-Device Identifier: 05415067028143
• UDI-Public: 05415067028143
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: H070005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 10/31/2024
• Device Model Number: 9-VSDMPIHDE-024
• Device Catalogue Number: 9-VSDMPIHDE-024
• Device Lot Number: 7262135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/12/2020
• 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 P.I. MUSCULAR VSD OCCLUDER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Weight: 63