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

Catalog Number	S-65-150-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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 identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified lesion in the non-tortuous 6.7mm-diameter distal superficial femoral artery (sfa).After atherectomy, and pre-dilatation with a 7.0x150 armada balloon (inflated to 4 to 6 atmospheres for 3 minutes), a 6.5x150 6f 120cm supera peripheral self-expanding stent system (sess) was prepped per the instructions for use (ifu) and was advanced without difficulty to the lesion.The thumbslide was pushed without difficulty and all of the stent appeared to have completely deployed under fluoroscopy.The thumbslide was then retracted and the system lock and deployment lock were in the locked position per the ifu.However, when attempting to retract the delivery system, resistance was felt and it was discovered that a proximal stent strut was caught on a delivery system ratchet.Force was not applied.In an attempt to free the delivery system from the stent, the physician twisted/rotated the supera delivery system in place, popping the ratchet off of the stent strut, freeing the stent from the ratchet.The supera delivery system was then able to be withdrawn without further difficulty and there was no elongation or any other damage to the deployed stent; the stent was deployed completely within the desired target area.There were no adverse patient effects and no occurrence of a clinically significant delay.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: 6762094
• Report Number: 2024168-2017-06354
• Device Sequence Number: 11135679
• Product Code: NIP
• UDI-Device Identifier: 08975370026399
• UDI-Public: 08975370026399
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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: 09/30/2018
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 6101061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR