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

Model Number	9-AVP2-010
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Serious Injury
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) 2022, a 14x5mm amplatzer valvular plug 3 and a 10mm amplatzer vascular plug 2 were implanted into a patient to close an aortic paravalvular leak.The device was sized using transthoracic echocardiogram (tte).During the procedure, after implantation, it was noted that there was a mild residual leak.It was decided to implant a third device.Upon advancement of the 6f delivery sheath, both the amplatzer valvular plug 3 and amplatzer vascular plug 2 embolized into the iliac artery.The devices were snared and removed from patient anatomy.A new 14x5mm amplatzer valvular plug 3 and a 12mm amplatzer vascular plug 2 were successfully implanted to complete the procedure.The patient is reported to be stable.It is believed that the device embolized due to the sheath advancement of the third device.The patient remained hemodynamically stable throughout the procedure.There was a clinically significant delay in procedure due to device retrieval, and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
An event of residual shunt and device embolism 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 specifications.Information from the field indicated that the device embolism was related to the sheath advancement beside the implanted device during the implant procedure.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Clinical study patient id - (b)(6).It was reported that on (b)(6) 2022, a 14x5mm amplatzer valvular plug 3 and a 10mm amplatzer vascular plug 2 were implanted into a patient to close an aortic paravalvular leak.The devices were sized using transthoracic echocardiogram (tte).During the procedure, after implantation, it was noted that there was a mild residual leak.It was decided to implant a third device.Upon advancement of the 6f delivery sheath, both the amplatzer valvular plug 3 and amplatzer vascular plug 2 embolized into the iliac artery.The devices were snared and removed from patient anatomy.A new 14x5mm amplatzer valvular plug 3 and a 12mm amplatzer vascular plug 2 were successfully implanted to complete the procedure.It is believed that the device embolized due to the sheath advancement of the third device.The patient remained hemodynamically stable throughout the procedure.There was a clinically significant delay in procedure due to device retrieval.The patient was reported to be stable.

• 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: 15738984
• Report Number: 2135147-2022-01949
• Device Sequence Number: 6317730
• Product Code: KRD
• UDI-Device Identifier: 00811806010380
• UDI-Public: 00811806010380
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-010
• Device Catalogue Number: 9-AVP2-010
• Device Lot Number: 8297906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/29/2022
• 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 Sex: Male