MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number	S-45-080-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Incorrect anatomy.Evaluation summary: visual inspections were performed on the returned device.The deployment issue and stent elongation was not confirmed.The tip detachment was confirmed.It should be noted that the supera instruction for use states: the supera peripheral stent system is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery and / or proximal popliteal artery.It could not be determined if using the supera in the tibial artery caused or contributed to the difficulties.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 incidents.The investigation determined the reported difficulties were due to case circumstances.It is likely that the distal sheath of the supera delivery system was entrapped or bent in the anatomy such that the ratchet was unable to engage the stent properly preventing it from fully releasing.The stent elongation and tip detachment was the result of retracting the delivery system with the partially deployed stent into the introducer sheath.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 lesion in the right anterior tibial artery.Following pre-dilatation, an attempt to implant a 4.5x80mm supera peripheral stent in a 2.5mm size vessel was made; however, the stent elongated over 10% from outside the procedure sheath.The thumb slide was retracted and the tip separated when the stent system was being removed, but it remained in the procedure sheath.The system was removed as a unit under fluoroscopy.The procedure was successfully completed with manual pressure.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: SUPERA 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: 7334415
• Report Number: 2024168-2018-01760
• Device Sequence Number: 16339148
• Product Code: NIP
• UDI-Device Identifier: 08975370026252
• UDI-Public: 08975370026252
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/13/2018

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: 08/31/2018
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 6092761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 03/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1