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

Catalog Number	9-AVP2-014
Medical Device Problem Codes	Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 - date of event is estimated.D4 - the udi number is not known as the part and lot numbers were not provided.Attachment: article titled "embolization using a debranch left common carotid artery stump for gutter endoleak after thoracic endovascular aortic repair with the double-debranching and chimney technique".As reported in a research article, "embolization using a debranch left common carotid artery stump for gutter endoleak after thoracic endovascular aortic repair with the double-debranching and chimney technique" a 14mm amplatzer vascular plug ii was used off-label for implant to embolize the left subclavian artery during a concomitant tevar with double-debranching and chimney technique procedure on an 88-year-old male who underwent thoracic endovascular aortic repair (tevar) with double-debranching and chimney technique for aortic arch aneurysm and presented with residual shunt post procedure.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determinena.
Event or Problem Description
The article, "embolization using a debranch left common carotid artery stump for gutter endoleak after thoracic endovascular aortic repair with the double-debranching and chimney technique", was reviewed.The article presented a case study of an 88-year-old male who underwent thoracic endovascular aortic repair (tevar) with double-debranching and chimney technique for aortic arch aneurysm.It was reported that on an unknown date, a 14mm amplatzer vascular plug ii was chosen for implant to embolize the left subclavian artery during a concomitant tevar with double-debranching and chimney technique procedure.Post-procedure it was noted there was a residual shunt.A decision was made for reintervention and a sheath was placed at the stump and an angiographic catheter and guidewire were used to retrograde cannulate the gutter beside the chimney graft, and coil embolization was performed.The article concluded that embolization from a debranched left common carotid artery stump is useful for endoleaks after tevar employing the chimney and debranching technique.[the primary author was yu kawahara, department of cardiovascular surgery, yamagata prefectural central hospital, yamagata, japan] peri-procedural complications included residual shunt, surgical intervention, and off label use.

• 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: 17904861
• Report Number: 2135147-2023-04409
• Device Sequence Number: 7776896
• Product Code: KRD
• UDI-Device Identifier: 00811806010403
• UDI-Public: 00811806010403
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/10/2023

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 Catalogue Number: 9-AVP2-014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 88 YR
• Patient Sex: Male