MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP2-010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	04/13/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
An event of st-elevation, decrease in blood pressure and death were reported after the occluder implant.Based on information from field the possible cause of the procedural complications was a wire perforation into the myocardium that could have lead to a rupture.Information from the field also indicated that the device was released with good result and there was no complaint reported against either device.Abbott requested for operative notes and imaging, this was not provided.A returned device assessment could not be performed as the device remained implanted and 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.
Event or Problem Description
This event is being conservatively reported as the cause of the patient's death is unknown.It was reported that on (b)(6) 2022 , 12 mm amplatzer vsd muscular (vsd) and a 10 mm amplatzer vascular plug ii was selected for implant in a (b)(6) female patient with prior ventricular septal defect (vsd) surgical patch repair.The ventricular septum was then determined to be multi-fenestrated via transesophageal echocardiography (tee).The 12mm amplatzer vsd device was positioned successfully and without complication through one of the defects and deployed via internal jugular vein (ij) access.Another tunnel type defect was then crossed with a guidewire from the right ventricle (rv) side to the left ventricle (lv ) and closed with a 10 mm amplatzer vascular plug ii.Both devices were released with good result.The patient then began to have st-elevation and a marked decrease in blood pressure.The team began cardiopulmonary resuscitation (cpr) and performed all necessary protocols to alleviate the symptoms, but were inevitably unable to reverse the patient's condition.The patient expired after 30 + minutes of cpr with anesthesia support on (b)(6) 2022.The team and cardiovascular surgeon who had previously performed the vsd patch repair speculated that a wire perforation into the myocardium could have lead to a rupture, and likely was the cause of the procedural complications.There were no complaints against either device, or comments regarding adverse events due to any of the abbott products used in this procedure.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 14388240
• Report Number: 2135147-2022-00264
• Device Sequence Number: 4859164
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: 00811806010380
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 05/12/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 9-AVP2-010
• Device Catalogue Number: 9-AVP2-010
• Device Lot Number: 7931309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• 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: 12MM AMPLATZER VSD MUSCULAR OCCLUDER
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Sex: Female