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

Model Number	VSD Muscular Occluder
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, an 18mm amplatzer post-infarct muscular ventricular septal defect (vsd) occluder was selected for procedure.It was noted that during procedure the occluder embolized after being fully deployed.The decision was made to send the patient to surgery to explant the embolized occluder.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device embolism was reported.The device received at abbott was cut in half, consistent with damage during use.Due to the damage, dimensional and functional testing could not be performed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated the device was smaller than the size recommend in the instruction for use (ifu), which recommends a device 3mm larger than the defect be chosen, while this device was of similar size to the defect.This could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.D1: device name corrected to amplatzer muscular vsd occluder d4: catalog# and udi number corrected.H6: clinical code 4580 (insufficient information) was removed.Code 4582 added.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that: the dimensions of the defect were determined to be 15mm - 16 mm via transthoracic echocardiogram.A 10f non-abbott delivery sheath was used to implant the 8mm amplatzer muscular ventricular septal defect (vsd) occluder.The occluder appeared to be seated properly when it was released from the delivery sheath.During the procedure, it was observed that the occluder embolized into the patient's right ventricle 10 minutes after implant.The device was explanted in surgery.The patient had remained hemodynamically stable throughout the procedure.The patient did not display any clinical signs or symptoms post event.There was no clinically significant delay in the procedure and no adverse effects reported.The patient was stable at the time of report.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 n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15503592
• Report Number: 2135147-2022-01404
• Device Sequence Number: 7754974
• Product Code: MLV
• UDI-Device Identifier: 00811806011806
• UDI-Public: 00811806011806
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 08/31/2023
• Device Model Number: VSD Muscular Occluder
• Device Catalogue Number: 9-VSD-MUSC-008
• Device Lot Number: 6654297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 10F MULIN SHEATH
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown