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

Catalog Number	1012531-80
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 non-tortuous, mildly calcified right external iliac artery.A 9.0 x 80 mm absolute pro vascular stent delivery system (sds) was selected for the procedure.After pre-dilatation with an unspecified balloon dilatation catheter (bdc) the sds was advanced to the lesion and crossed.During deployment of the stent implant the thumbwheel would not turn far enough to complete the deployment of the stent.The sds with the partially deployed stent implant was pulled back through the introducer sheath and out of the anatomy.The procedure was halted at that point and the patient was rescheduled for a later date.Six days later the lesion was successfully treated with the deployment of a 10.0 x 60mm absolute pro vascular stent.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual dimensional and functional inspection was performed on the returned device.The failure to deploy and difficulty removing from the guide wire was not confirmed due to the condition of the returned device.It is possible that the distal sheath was entrapped or bent within the anatomy such that restriction was encountered while rotating the thumbwheel resulting in partial deployment; however, this could not be 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 was unable to determine a conclusive cause for the reported deployment difficulty.The difficulty removing from the guide wire was 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
Additional information: return device analysis found that the stent holder (inner member) of the absolute pro was returned separated on a versacore 035" guide wire.Follow-up with the account confirmed that there was resistance during removal of the stent delivery system with the guide wire; however, they could not recall anything about the separation.No additional information was provided.

• 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: 6323366
• Report Number: 2024168-2017-01119
• Device Sequence Number: 19026041
• Product Code: NIO
• UDI-Device Identifier: 08717648175800
• UDI-Public: (01)08717648175800(17)190519(10)6061461
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,consum
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2017

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: 05/19/2019
• Device Catalogue Number: 1012531-80
• Device Lot Number: 6061461
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/08/2017
• 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: SHEATH: 6F 55CM COOK
• Patient Age: 67 YR
• Patient Weight: 121