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

Model Number	9-VSD-MUSC-008
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of device migration was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use, arten600038217 - a, "the amplatzer¿ muscular vsd occluder is indicated for use in patients with a complex ventricular septal defect (vsd) of significant size to warrant closure (large volume left-to-right shunt, pulmonary hypertension, and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition.".
Event or Problem Description
It was reported that on (b)(6) 2021, an 8 mm amplatzer muscular vsd occluder was chosen for procedure of closing three paravalvular leaks of a mechanical mitral valve (unknown manufacturer).The 8 mm occluder was released in the first defect.Next, a 10 mm amplatzer muscular vsd occluder was successfully implanted in another leak using the 6 f amplatzer torqvue delivery system.During the release of the 10 mm occluder, it was discovered that the 8 mm occluder had dislodged within the heart due to being too small.The 8 mm occluder was successfully snared from the patient, and the patient did not experience any adverse events after retrieving the 8 mm occluder.A 12 mm amplatzer muscular vsd occluder was opened and prepared for the third defect, but it was never implanted into the patient.The decision was made to send the patient for surgical revision of the mitral valve at a later date.The doctor did not feel there was a significant delay despite having to snare the device.The patient remained hemodynamically stable throughout the procedure.The physician knew that this case was going to be difficult and that there was a chance that it would not be successful, but this procedure was performed in attempt to avoid sending the patient for surgical revision.No additional information was provided.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13111754
• Report Number: 2135147-2021-00592
• Device Sequence Number: 3395729
• Product Code: MLV
• UDI-Device Identifier: 00811806011806
• UDI-Public: 00811806011806
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/29/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 9-VSD-MUSC-008
• Device Catalogue Number: 9-VSD-MUSC-008
• Device Lot Number: 6234054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2021
• Initial Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 93 KG