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

Model Number	1012535-20
Medical Device Problem Codes	Off-Label Use (1494); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 incidents.It should be noted that the instructions for use (ifu), for the absolute pro, ce, states: ¿the absolute pro.035 peripheral self-expanding stent system is intended for the stenting of peripheral arteries as an adjunct to percutaneous transluminal angioplasty (pta) and for the palliation of malignant strictures in the biliary tree.¿ it is possible, the ifu deviation caused or contributed to the activation difficulty, however, this cannot be confirmed.Based on the information provided, the investigation was unable to determine a conclusive cause for the reported malposition.It may be possible that the delivery system interaction with the anatomy prevented smooth deployment causing the stent to jump forward under the retraction force of the deployment sheath, however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat a left cephalic outflow vein.An absolute pro was advanced to the lesion without resistance and deployment was initiated.While deploying the stent, it jumped and only covered part of the target lesion.Another stent was used to cover the uncovered portion of the lesion.It was confirmed that there was no issue with the thumbwheel mechanism.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• 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: 11577357
• Report Number: 2024168-2021-02447
• Device Sequence Number: 3052508
• Product Code: NIP
• UDI-Device Identifier: 08717648176043
• UDI-Public: 08717648176043
• 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
• Report Date (Section B): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 1012535-20
• Device Catalogue Number: 1012535-20
• Device Lot Number: 0091661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 64