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 Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The delivery system is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other two absolute pro vascular stents referenced are filed under separate medwatch reports.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right and left external iliac.The bilateral external iliac, common iliac, and the distal aorta were very calcified.Shockwave therapy was performed.The absolute pro (9090461) was advanced; however, it was believed the stent failed to deploy because the stent markers were not visible.The device was removed without issue.The same issue occurred with two other absolute pro devices (9080861, 9010261); it was believed the stents completely failed to deploy because the stent markers were not visible.No other attempts were made to stent.The films were reviewed, the stents were confirmed to have been deployed in the target vessels; however, the markers were not visible due to the patient anatomy.There were no reported adverse patient effects and no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.Visual testing was performed on the returned device.The visibility issue was not confirmed as the image clearly showed the balloon markers.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 determined the reported difficulties are case circumstances.It is likely that challenging anatomical conditions contributed to the visibility issue.As a result, the stents were reported to have not deployed prior to reaching the target lesion, although the stents were later confirmed to have deployed to the target lesion.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: 10248302
• Report Number: 2024168-2020-05572
• Device Sequence Number: 514723
• Product Code: NIP
• UDI-Device Identifier: 08717648175794
• UDI-Public: 08717648175794
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 08/11/2020

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: 07/31/2022
• Device Model Number: 1012531-60
• Device Catalogue Number: 1012531-60
• Device Lot Number: 9080861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 99