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

Model Number	9-VSD-MUSC-010
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 10mm amplatzer muscular vsd occluder was chosen for a ventricular septal defect (vsd) closure procedure using a 7f amplatzer torqvue delivery system.The patient was a 67-year-old female with a high muscular vsd that appeared post-myocardial infarction in 2024.The transesophageal echocardiogram (tee) showed baseline tricuspid regurgitation, right ventricular dysfunction, and a cavernous defect measuring 18 mm internally, with 7mm offset openings on the right and left sides with a septal width of 8mm.The left side of the defect showed sufficient rims; however, the right sided opening was mildly higher and nearer to the tricuspid valve leaflet.After placement of a guide wire, the physician determined they wanted to switch out the wire, and go bare across the septum with a new non-abbott wire.After placement of the new wire the physician was having difficulty crossing the defect with the sheath and dilator.There was a resistance felt and then decided to attempt an antegrade approach.The physician then went to an antegrade approach, at this point the wire had still been bare across the vsd at the md's request.The delivery system crossed the defect easily on antegrade approach, the left disc of the device deployed as expected, but the right disc of the device remained cobra-headed.The physician opened another 10mm amplatzer muscular vsd occluder, which also cobra-headed, which they attributed to not the device but the shape and size of the defect.The physician stated that they wanted both discs to be shaped as expected and felt this could be done from a retrograde approach.The procedure switched to a retrograde approach.On this second retrograde approach, they faced similar resistance when crossing the delivery system through the defect.Upon release of the resistance, and passage of the sheath and dilator through the defect and into the right ventricle, the tricuspid regurgitation became torrential.At this point, they called cardiothoracic surgeon and discussed and internally determined to go ahead and close the defect from the retrograde approach.The 10mm amplatzer muscular vsd occluder was attempted through 7f amplatzer torqvue delivery system.The right ventricular disc deployed as expected, then the left ventricular disc was deploying repeatedly within the center of the defect.The physicians decided to upsize the device to 14mm amplatzer muscular vsd occluder.There was no 8f amplatzer torqvue delivery system was available.They used sheath of a 8f amplatzer torqvue exchange system was used with the dilator and delivery cable of a 8f amplatzer torqvue delivery system.The 14mm amplatzer muscular vsd occluder was deployed as expected, interrogation after placement was done in four chamber and trans-gastric views on tee, and the device was determined to be stable with no flow through or around the device.The device was released and final device placement was confirmed again with four-chamber and trans-gastric tee, as well as intracardiac echocardiography (ice).The patient was reported 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 on (b)(6) 2026, a 10mm amplatzer muscular vsd occluder was chosen for a ventricular septal defect (vsd) closure procedure using a 7f amplatzer torqvue delivery system.The patient was a 67-year-old female with a high muscular vsd that appeared post-myocardial infarction in 2024.The transesophageal echocardiogram (tee) showed baseline tricuspid regurgitation, right ventricular dysfunction, and a cavernous defect measuring 18 mm internally, with 7mm offset openings on the right and left sides with a septal width of 8mm.The left side of the defect showed sufficient rims; however, the right sided opening was mildly higher and nearer to the tricuspid valve leaflet.After placement of a guide wire, the physician determined they wanted to switch out the wire and go bare across the septum with a new non-abbott wire.After placement of the new wire the physician was having difficulty crossing the defect with the sheath and dilator.There was a resistance felt and then decided to attempt an antegrade approach.The physician then went to an antegrade approach, at this point the wire had still been bare across the vsd at the md's request.The delivery system crossed the defect easily on antegrade approach, the left disc of the device deployed as expected, but the right disc of the device remained cobra-headed.The physician opened another 10mm amplatzer muscular vsd occluder, which also cobra-headed, which they attributed to not the device but the shape and size of the defect.The physician stated that they wanted both discs to be shaped as expected and felt this could be done from a retrograde approach.The procedure switched to a retrograde approach.On this second retrograde approach, they faced similar resistance when crossing the delivery system through the defect.Upon release of the resistance, and passage of the sheath and dilator through the defect and into the right ventricle, the tricuspid regurgitation became torrential.At this point, they called cardiothoracic surgeon and discussed and internally determined to go ahead and close the defect from the retrograde approach.The 10mm amplatzer muscular vsd occluder was attempted through 7f amplatzer torqvue delivery system.The right ventricular disc deployed as expected, then the left ventricular disc was deploying repeatedly within the center of the defect.The physicians decided to upsize the device to 14mm amplatzer muscular vsd occluder.There was no 8f amplatzer torqvue delivery system was available.They used sheath of a 8f amplatzer torqvue exchange system was used with the dilator and delivery cable of a 8f amplatzer torqvue delivery system.The 14mm amplatzer muscular vsd occluder was deployed as expected, interrogation after placement was done in four chamber and trans-gastric views on tee, and the device was determined to be stable with no flow through or around the device.The device was released and final device placement was confirmed again with four-chamber and trans-gastric tee, as well as intracardiac echocardiography (ice).The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported stable.
Additional Manufacturer Narrative
An event of device deformity 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 defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the information received, the cause of the reported incident could be due to patient's anatomy.However, this cannot be conclusively determined.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: 24469615
• Report Number: 2135147-2026-01204
• Device Sequence Number: 21415532
• Product Code: MLV
• UDI-Device Identifier: 00811806011813
• UDI-Public: (01)00811806011813(17)280930(10)10041757
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-VSD-MUSC-010
• Device Catalogue Number: 9-VSD-MUSC-010
• Device Lot Number: 10041757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female