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

Catalog Number	9-VSD-MUSC-018
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 16mm amplatzer muscular vsd occluder was selected for implant on (b)(6) 2024 using a 9f amplatzer torqvue delivery system.The ampulla was measured at 18.8mm.The tightest restriction of the duct was 12x16.6mm.The pulmonary artery opening was 18mm and the length was 22.5mm.Angiography was used to determine sizing.Fluoroscopy and echocardiogram was used for the procedure.During the procedure the device was placed on the patent ductus arteriosus (pda) and it was determined that the size of the device was too small.The device was removed from the patient and replaced with an 18mm amplatzer muscular vsd occluder.The device was implanted.The patient remained hemodynamically stable throughout the procedure.Several hours post-implant the device was noted to have embolized to the right pulmonary artery and caused a partial blockage.The device was snared with a transcatheter snare and removed from the patient.An 18mm amplatzer post-infarct vsd occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.The device was determined to be too small.The device was removed from the patient and replaced with a new 22mm amplatzer post-infarct vsd occluder.The size of the device was unsatisfactory.It was determined that the patient would have a surgical closure of the pda.The physician believes the embolization was caused by a large pda.There were no adverse effects to the patient.The patient status was stable.
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 a 16mm amplatzer muscular vsd occluder was selected for implant on (b)(6) 2024 using a 9f amplatzer torqvue delivery system.The ampulla was measured at 18.8mm.The tightest restriction of the duct was 12x16.6mm.The pulmonary artery opening was 18mm and the length was 22.5mm.Angiography was used to determine sizing.Fluoroscopy and echocardiogram was used for the procedure.During the procedure the device was placed on the patent ductus arteriosus (pda) and it was determined that the size of the device was too small.The device was removed from the patient and replaced with an 18mm amplatzer muscular vsd occluder.The device was implanted.The patient remained hemodynamically stable throughout the procedure.Several hours post-implant the device was noted to have embolized to the right pulmonary artery and caused a partial blockage.The device was snared with a transcatheter snare and removed from the patient.An 18mm amplatzer post-infarct vsd occluder was selected for implant using a 10f amplatzer trevisio intravascular delivery system.The device was determined to be too small.The device was removed from the patient and replaced with a new 22mm amplatzer post-infarct vsd occluder.The size of the device was unsatisfactory.It was determined that the patient would have a surgical closure of the pda.The physician believes the embolization was caused by a large pda.There were no adverse effects to the patient.The patient status was stable.
Additional Manufacturer Narrative
An event of device embolization to the right pulmonary artery and a partial blockage 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Information from field indicated that the physician believed that the embolization was caused by large pda and that the device was too small.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 19013109
• Report Number: 2135147-2024-01418
• Device Sequence Number: 20873598
• Product Code: MLV
• UDI-Device Identifier: 00811806011851
• UDI-Public: (01)00811806011851(17)261130(10)8255211
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

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 Catalogue Number: 9-VSD-MUSC-018
• Device Lot Number: 8255211
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2021
• 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: 23 YR
• Patient Sex: Female