MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	1012530-80
Medical Device Problem Codes	Premature Activation (1484); Mechanical Jam (2983); Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The additional absolute pro referenced is being filed under a separate medwatch report.A visual inspection was performed on the returned device.The failure to deploy, premature deployment and resistance with the thumbwheel were not confirmed as the stent was already fully deployed and not returned.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 are due to case circumstances.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 moderately calcified right external iliac artery that did not have any tortuosity.The access point was the left common femoral artery and they used a 6 french sheath.They advanced the first 8.0 x 80 mm absolute pro vascular self-expanding stent (ses) system to the lesion.The device was then unlocked; however, the thumbwheel would not turn.Therefore, the device was removed from the anatomy and another 8.0 x 80 mm absolute pro vascular ses was advanced to the lesion.However, the same issue occurred with the thumbwheel.The device was then removed from the anatomy and a 8.0 x 80 mm non-abbott stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Analysis of the returned device revealed that the stent was not returned with the device and therefore, it may have been deployed in the patient anatomy.

• Brand Name: ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
• Common Device Name: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7802584
• Report Number: 2024168-2018-06440
• Device Sequence Number: 16771234
• Product Code: NIO
• UDI-Device Identifier: 08717648175725
• UDI-Public: 08717648175725
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2018

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: 07/31/2020
• Device Catalogue Number: 1012530-80
• Device Lot Number: 7081561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/21/2018
• 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: STENT: ABSOLUTE PRO 8.0X80
• Outcome Attributed to Adverse Event: Other