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

Model Number	1012530-60
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a fistula graft in the subclavian vein and the 8.0x60 mm absolute pro vascular self expanding stent became stuck on the guide wire and could not be delivered.Both the stent and the guide wire had to be removed together.A new stent and a new guide wire were used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.The product risk assessment identifies this as a foreseeable event.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar complaints.Based on the information provided, the investigation was unable to determine a conclusive cause for the reported difficult to advance and difficult to remove.It may be possible that during use, the clearance between the guide wire lumen of the absolute pro and the guide wire was reduced causing the devices to become stuck together, resulting in the catheter inability to advance and the subsequent difficult to remove.However, this could not be confirmed because the device was not returned.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.

• 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: 10120445
• Report Number: 2024168-2020-04762
• Device Sequence Number: 3636223
• Product Code: NIP
• UDI-Device Identifier: 08717648175718
• UDI-Public: 08717648175718
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: 10/31/2020
• Device Model Number: 1012530-60
• Device Catalogue Number: 1012530-60
• Device Lot Number: 7111861
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR