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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, an 8mm amplatzer muscular ventricular septal defect (vsd) occluder was successfully implanted in a patient.It was noted that post-implant the occluder embolized into the patient's pulmonary artery.The decision was made to attempt a percutaneous extraction of the occluder, but was unsuccessful.The patient was then sent to surgery to have the 8mm amplatzer muscular (vsd) occluder explanted.The patient was stable at the time of report.No additional information was provided.
Additional Manufacturer Narrative
An event of device embolization into the pulmonary artery was reported.A returned device 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.The cause of the reported event could not be conclusively determined but the use of a smaller size device may have contributed to the device embolization.
Event or Problem Description
It was reported that on (b)(6) 2023, an 8mm amplatzer muscular ventricular septal defect (vsd) occluder was successfully implanted in a patient.It was noted that post-implant the occluder embolized into the patient's pulmonary artery.The decision was made to attempt a percutaneous extraction of the occluder, but was unsuccessful.The patient was then sent to surgery to have the 8mm amplatzer muscular (vsd) occluder explanted.The patient was stable at the time of report.Subsequent to the previously filed report, additional information was received that a 6f amplatzer torqvue delivery system was used during the implant procedure.The 8mm amplatzer muscular ventricular septal defect (vsd) occluder was sized using angiography and transthoracic echocardiography.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.It was noted that the 8mm amplatzer muscular (vsd) occluder embolization was confirmed using transthoracic echocardiography.It was also noted that the occluder completely dislodged and embolized into the patient's right pulmonary artery.The patient did not suffer any clinical symptoms as a result of the embolization, but was hospitalized.The patient was doing well and discharged at the time of report.The cause of the occluder embolization is attributed to the occluder being to small for the patient's defect.There is no allegation of malfunction against the8mm amplatzer muscular (vsd) occluder or procedure.

• 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: 16269116
• Report Number: 2135147-2023-00328
• Device Sequence Number: 20451742
• Product Code: MLV
• UDI-Device Identifier: 00811806011806
• UDI-Public: 00811806011806
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 06/06/2023

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: 04/30/2025
• Device Model Number: VSD MUSCULAR OCCLUDER
• Device Catalogue Number: 9-VSD-MUSC-008
• Device Lot Number: 7523366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 06/05/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• 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; Life Threatening; Hospitalization
• Patient Sex: Unknown