MAUDE Adverse Event Report: ABBOTT VASCULAR ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING PERIPHERAL STENT SYSTEM

Model Number	1012529-30
Medical Device Problem Codes	Off-Label Use (1494); Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Event or Problem Description
It was reported that the procedure was to treat an arteriovenous fistula in the left basilic.A fistulagram was performed.A 7x30mm absolute pro stent was deployed at the lesion without issue.However, it was then noted that the stent implant was not fully apposed to the vessel wall and had migrated distally towards the left auxiliary.It was decided to dilate the stent implant in place (non target lesion).A 7x40mm absolute pro was used to successfully complete the procedure at the target lesion.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.It should be noted that the indications section of the absolute pro instruction for use states: ¿the absolute pro vascular self-expanding stent system is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm and 9.1 mm and lesion lengths up to 90 mm.¿ in this event, it could not be determined if using the absolute pro off-label caused or contributed to the difficulties encountered.The investigation was unable to determine a cause for the reported malposition and migration resulting in unexpected medical intervention to dilate the stent implant in place in the non-target lesion.It may be possible that the stent diameter was smaller than the diameter of the arteriovenous fistula at the deployment location causing poor wall apposition resulting in migration; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12062936
• Report Number: 2024168-2021-05404
• Device Sequence Number: 19896170
• Product Code: NIP
• UDI-Device Identifier: 08717648175619
• UDI-Public: 08717648175619
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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 Expiration Date: 04/30/2023
• Device Model Number: 1012529-30
• Device Catalogue Number: 1012529-30
• Device Lot Number: 0052061
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 47