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

Model Number	1012534-30
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the left superior femoral artery.One stent was successfully placed.The 6.0x30mm absolute pro vascular self expanding stent system (sess) was advanced with resistance noted.Once the sess was advanced to the previously placed stent, it was noted the stent was sticking out from the sheath approximately 1mm and would not advance through the stent.The sess was removed without issue and the procedure completed with another device.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
The device was returned.Visual and functional inspection was performed on the returned device.The premature deployment was confirmed.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 of the reported lot revealed no other incidents.The investigation determined that the reported difficulties were likely due to case circumstances.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: 10465485
• Report Number: 2024168-2020-07204
• Device Sequence Number: 3092122
• Product Code: NIP
• UDI-Device Identifier: 08717648175978
• UDI-Public: 08717648175978
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/10/2020

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: 11/30/2020
• Device Model Number: 1012534-30
• Device Catalogue Number: 1012534-30
• Device Lot Number: 7121961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 IMPLANTED STENT
• Patient Age: 80 YR
• Patient Weight: 65