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

Model Number 9-PLUG-014

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 14mm amplatzer vascular plug was chosen for implant with a 2.21mm inner diameter non-abbott delivery sheath to occlude a puncture of the subclavian artery measured 8-9mm diameter following a thoracic bypass graft to modify blood flow for a planned 2 stage thoracic endovascular aortic repair (tevar).The device was implanted and complete occlusion was confirmed via angiography.The first stage of tevar was performed as scheduled and procedure was completed.It was reported the following day, on (b)(6) 2023, a contrast-enhanced computed tomography (ct) scan revealed the vascular plug had embolized and completely dislodged from the subclavian artery origin to near the abdominal aneurysm at the distal renal artery.It was reported there was no partial or complete obstruction/blockage of blood flow caused by the embolized device.The second stage of the tevar procedure was conducted immediately.Prior to stent graft placement, an attempt to retrieve the vascular plug was made using a snare device but was unsuccessful.A decision was made to complete the tevar by inserting the stent graft per normal procedure to position the vascular plug between the stent graft and the vascular wall of the abdominal aneurysm, thereby restricting further movement of the plug.It was reported the patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure due to this event.The patient status was reported as discharged.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of device embolization into the abdominal aneurysm was reported.Based on the received information, the cause of the reported event could not be conclusively determined.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Imaging from the field indicated that measured diameters along the aorta beginning with the ascending aorta and progressing through the aortic arch, descending aorta, abdominal aorta, iliac and femoral arteries bilaterally.There are two tevar stents drawn into the ascending aorta and aortic arch/descending/abdominal aorta along with stent in the innominate artery and left subclavian artery.The location of the embolized avp (14mm) is not drawn, but reported to be in the abdominal aorta at the distal renal artery.The avp could not be retrieved with a transcatheter snare and the second tevar was implanted intentionally to cover the embolized avp.Based on the received information, the root cause of the reported event could not be conclusively determined.However, it's uncertain whether this may have any long-term sequela as a result of the avp being trapped against the aortic wall.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.

• Brand Name: AMPLATZER VASCULAR PLUG
• Type of Device: 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: 17219304
• MDR Text Key: 318072035
• Report Number: 2135147-2023-02833
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00811806011493
• UDI-Public: 00811806011493
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 9-PLUG-014
• Device Catalogue Number: 9-PLUG-014
• Device Lot Number: 8423459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 08/09/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male