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	11/25/2016
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.(b)(4).The device was received.Visual inspection was performed on the returned device.The reported deployment issue was unable to be confirmed as the stent had already been fully deployed.The tip separation was confirmed.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.It should be noted that the supera instructions for use (ifu) states: under fluoroscopy, slowly advance the thumb slide to the distal most position on the handle.Confirm under fluoroscopy that the entire supera stent has emerged from the outer sheath and is released.Based on the information reviewed, 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 during the procedure to treat a mildly to moderately calcified lesion in the mildly tortuous, diffusely diseased 4.5mm proximal popliteal to superficial femoral artery region, after performing pre-dilatation via inflation to nominal pressure for one minute with an unspecified 45.0x120mm balloon, a 4.5mm x 80mm x 120cm 6fr supera peripheral self-expanding stent system (sess) was prepared per the instructions for use and was advanced via right femoral artery access past the guiding catheter and to the target lesion without difficulty.The thumbslide was retracted into the proximal-most position without difficulty, the deployment lock was rotated to the left without issue, then the thumbslide was advanced distally, but, reportedly, the final distal thumb push was inadvertently not performed on the thumbslide, resulting in incomplete deployment of the supera stent; the proximal end of the stent was not completely released from the sheath.The partially expanded stent and its delivery system were reportedly able to be retracted from the anatomy and through the sheath without difficulty and without damage to the vessel.Another unspecified device was successfully used to treat the lesion.There were no adverse patient effects and no occurrence of a clinically significant delay.The abbott vascular returned goods lab received the supera without its stent and with its inner member and inner member jacket separated at the distal end of the ratchet stem tip, and not returned.Additional information received confirmed that the tip and stent did not separate in the patient; it was removed intact with no snaring required.The tip and stent separation had occurred post procedure and these pieces were discarded.No additional 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: 6354400
• Report Number: 2024168-2017-01469
• Device Sequence Number: 744435
• Product Code: NIP
• UDI-Device Identifier: 08975370026252
• UDI-Public: (01)08975370026252(17)171130(10)5120461
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Type of Report: Initial
• Report Date (Section B): 02/23/2017

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: 11/30/2017
• Device Catalogue Number: S-45-080-120-P6
• Device Lot Number: 5120461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 46