MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER POST-INFARCT VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	POST INFARCT MUSCULAR VSD OCCLUDER
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	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
This event is being reported for malfunction due to the deformation on the 16mm amplatzer post-infarct muscular vsd occluder.The pericardial effusion/cardiac tamponade is related to the non-abbott 0.035 glide catheter.It was reported on (b)(6) 2022, a 16mm amplatzer post-infarct muscular vsd occluder was selected for implant for post infarct ventricular septal defect (pi vsd).It was noted that approximately 6 weeks prior to implant procedure the patient experienced a significant left ventricular (lv) myocardial infarction resulting in a formation of pi vsd near the apex of both the left and right ventricles.The patient also suffered a number of pericardial effusions that were noted immediately following the infarction.During deployment a cobra deformation was noted on the initial attempt.The device was recaptured and a second deployment was attempted however a deformation was noted again.During this time, under transesophageal echocardiogram (tee), an effusion was noted and was getting larger.It was decided to recapture the device again and deploy for a third time however, the cobra shape appeared again and the proximal disk was still captured in the sheath.The patient blood pressure started to drop considerably and became hemodynamically unstable.It was noted on echo that the ventricles were not squeezing well due to the pericardial effusion and a pericardiocentesis was performed.Ultimately, the patient was transferred to open heart surgery where the vsd was surgically repaired and the physician commented that cause of the pericardial effusion was likely from a perforation by the non-abbott 0.035 glide catheter.
Additional Manufacturer Narrative
An event of cobra shaped deformity could not be confirmed.The device was returned to abbott for investigation and the device met functional and dimensional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported incident could not be conclusively determined.Please note, per the amplatzer post-infarct muscular vsd occluder instructions for use instructions for use: do not release the amplatzer¿ post-infarct muscular vsd occluder from the delivery cable if the device does not conform to its original configuration or if the device position is unstable.Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace it with a new device.".
Event or Problem Description
Subsequent to the previously filed report, additional information was received that there was no anatomical interference while deploying the occluder.There was no angulation or kink in the delivery system upon deployment.

• Brand Name: AMPLATZER POST-INFARCT 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: 13967308
• Report Number: 2135147-2022-00113
• Device Sequence Number: 19901370
• Product Code: MLV
• UDI-Device Identifier: 05415067028105
• UDI-Public: 05415067028105
• 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
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 08/09/2022

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 Expiration Date: 03/31/2026
• Device Model Number: POST INFARCT MUSCULAR VSD OCCLUDER
• Device Catalogue Number: 9-VSDMPIHDE-016
• Device Lot Number: 7876744
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TORQVUE 45 ITV 9-ITV10F45/80
• Patient Age: 83 YR
• Patient Sex: Female