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

Model Number	9-ASD-MF-018
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
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) 2021, a 18mm amplatzer cribriform occluder was selected for implant.During placement, it was deemed too small.While attempting to re sheath the 18mm amplatzer cribriform occluder the device would not enter despite strong force.It was thought that the distal tip of the amplatzer¿ trevisio¿ intravascular delivery system sheath somehow folded-in on itself causing issues with retrieving the device.The hospital had no exchange delivery system so the physician cut the tapered end of the dilator in order to pass it over the delivery cable and straighten the distal tip of the sheath, however, they could not get the cut dilator over the delivery cable.It was then decided to use a 6f delivery sheath to push out the tip of the 9f delivery sheath.The 9f sheath was cut to remove enough of the proximal end to allow the 6f sheath to reach the end.This strategy worked and the device was recaptured without issue.The device was inspected and profile the right disc appeared oval instead of flattened.A 25mm amplatzer cribriform occluder was successfully implanted.The patient remained hemodynamically stable throughout the procedure.The procedure was significantly delayed because of the difficulty in retrieving the 18mm device.Manufacturer report number: 2135147-2021-00093.
Additional Manufacturer Narrative
An event of difficulty retracting the device was reported.The investigation confirmed the device met functional and dimensional 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.Please note, per the instructions for use, artmt100092301 revision b table t1, that a 8 french delivery system is recommended for use with an 18mm amplatzer cribriform occluder, not a 9french.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11466324
• Report Number: 2135147-2021-00094
• Device Sequence Number: 14333223
• Product Code: MLV
• UDI-Device Identifier: 00811806010281
• UDI-Public: 00811806010281
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 9-ASD-MF-018
• Device Catalogue Number: 9-ASD-MF-018
• Device Lot Number: 6496617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/02/2021
• 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: 9-ATV09F45/80, 7613180
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Weight: 17