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

Catalog Number	9-AVP2-010
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature article: "growing renal vein aneurysm treated by endovascular repair: a case report and literature review".As reported in a research article, "growing renal vein aneurysm treated by endovascular repair: a case report and literature review", on an unknown date, a 10mm amplatzer vascular plug (avp) ii was chosen for implant to occlude the renal vein aneurysm in a 74-year-old male patient with chronic atrial fibrillation, moderate mitral regurgitation, cerebral infarction.Peri-procedural complications included device embolization, foreign body in patient, improper or incorrect method or 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 determined.Please note per the instructions for use, the amplatzer¿ vascular plug ii is indicated for arterial and venous embolizations in the peripheral vasculature.
Event or Problem Description
The article, "growing renal vein aneurysm treated by endovascular repair: a case report and literature review", was reviewed.The article presented a case study of a 74-year-old male patient with chronic atrial fibrillation, moderate mitral regurgitation, cerebral infarction, prior fall incidents that required emergency visit, and a renal vein aneurysm (rva) that measured 17.1mm in (b)(6) 2015 and 35.7mm in (b)(6) 2019.It was reported that on an unknown date, a 10mm amplatzer vascular plug (avp) ii was chosen for implant to occlude the renal vein aneurysm.It was also reported two 22mm amplatzer vascular plug ii's were concomitantly placed in the aneurysm sac to reduce the empty space and promote thrombus formation in the aneurysm lumen.After the 10mm avp ii was released, after a while, the device dislodged into the aneurysm.The device was not recaptured or explanted.A decision was made to implant a 16mm amplatzer vascular plug ii into the neck of the aneurysm.The final angiogram demonstrated complete disappearance of flow into the aneurysmal sac.The aneurysm shrank and was completely resolved by 12 months after endovascular treatment.The article concluded that the authors successfully repaired a primary rva using avp ii.They believe that vascular plugs are a useful and safe option in the treatment of rva.This appears to represent the first description of primary rva successfully treated endovascularly using vascular plugs.(b)(6).

• 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: 18758363
• Report Number: 2135147-2024-00812
• Device Sequence Number: 12391397
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: 00811806010380
• 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): 02/22/2024

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-AVP2-010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/22/2024
• 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: Disability
• Patient Age: 74 YR
• Patient Sex: Male