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

Model Number	1012531-60
Medical Device Problem Codes	Difficult to Remove (1528); Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A visual and functional analysis was performed on the returned unit.The reported partial stent deployment was not confirmed as the stent was already fully deployed and not returned.The resistance rotating the thumbwheel was confirmed.The difficult to remove was unable to be tested as it was the result of interaction with the anatomy.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 similar incidents reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal shaft was entrapped, kinked or restricted within the anatomy (possibly over the aortic bifurcation) causing resistance between the shaft lumens preventing the thumbwheel from rotating; however, this could not be confirmed.The chatter marks and kinks noted on the distal sheath are consistent with the sheath being bent over a tight radius, further suggesting that anatomical conditions may have contributed to the difficulties encountered.The resistance noted with the anatomy during removal was likely due to withdrawing the ses with the stent partially deployed resulting in the stent being fully deployed in an unintended location.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a tortuous external iliac artery.A 9.0x60mm absolute pro self-expanding stent system (sess) was advanced with a.035 unspecified guide wire and upon attempting to deploy the thumbwheel would not advance; however, the stent was partially deployed.During removal the stent met resistance with anatomy and the device fully deployed.The stent remains implanted in healthy tissue, but not at the intended site.The sess and sheath were removed and another unspecified stent was used to successfully complete the procedure.There was 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: 10984154
• Report Number: 2024168-2020-10366
• Device Sequence Number: 16784272
• Product Code: NIP
• UDI-Device Identifier: 08717648175794
• UDI-Public: 08717648175794
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2020

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: 02/28/2023
• Device Model Number: 1012531-60
• Device Catalogue Number: 1012531-60
• Device Lot Number: 0030661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/10/2020
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 107