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

Model Number	1012534-80
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption number e2019001.The device 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.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the right superficial femoral artery.A 6x80mm absolute pro self-expanding stent system (sess) had visibility issues, and the stent was deployed prior to reaching the target lesion despite not knowing the stent's location.The stent was nowhere to be found and could not be confirmed to be outside the patient anatomy.After removal, a bunched tip was noted on the distal end of the delivery catheter.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported difficulties were not confirmed as the stent was already deployed.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 revealed no other complaints reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that anatomical conditions contributed to the visibility issue.As a result, the stent was reported to have deployed prior to reaching the target lesion, although the stent was unable to be found.Returned analysis noted that the approximately 4cm of the distal end of the sheath was separated and not returned and the sheath material at the separation was jagged.It is possible that the stent was partially deployed and during removal, the stent along with the separated portion of the distal sheath detached within the introducer sheath and therefore was unable to be located.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: returned device analysis identified a separated portion of the sheath of the 6x80mm absolute pro self-expanding stent system (sess).Although this separation was not noted by the account, it was confirmed to not be in the patient anatomy.No additional information was provided.

• Brand Name: ABSOLUTE PRO VASCULAR
• Common Device Name: SELF EXPANDING PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9304887
• Report Number: 2024168-2019-13414
• Device Sequence Number: 19423835
• Product Code: NIP
• UDI-Device Identifier: 08717648176005
• UDI-Public: 08717648176005
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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: 04/30/2022
• Device Model Number: 1012534-80
• Device Catalogue Number: 1012534-80
• Device Lot Number: 9052261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 01/28/2020
• 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: 88