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

Catalog Number	S-60-100-120-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).The device was not returned for analysis.It should be noted that in the supera instructions for use (ifu), the recommended pre-dilatation diameter for a 6.0mm stent is to use a balloon diameter greater than 6.0mm.It is possible that failing to pre-dilate the lesion site as instructed in the ifu contributed to the reported difficulties.With the vessel diameter being smaller than 6.0mm to accommodate the stent diameter, the stent would likely have elongated likely preventing the stent from fully releasing from the delivery system; however, this could not be 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.The investigation was unable to determine a conclusive cause for the deployment issue.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 located in the popliteal artery.The artery was 6.0 in diameter.Pre-dilatation was performed with a 5.0 balloon catheter.The 6.0x100mm supera stent delivery system was advanced to the lesion without issue and after unlocking the final lock the stent was believed to be deployed; however, after removal of the delivery catheter from the anatomy the stent implant was observed to be still attached to the delivery catheter.Retraction was performed while using intravascular ultrasound (ivus).A new 6 x 120 mm supera stent delivery system was used to complete the case without further issue.No adverse patient effects or clinically significant delay in the procedure were reported.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: 7304526
• Report Number: 2024168-2018-01455
• Device Sequence Number: 2300458
• Product Code: NIP
• UDI-Device Identifier: 08717648211829
• UDI-Public: 08717648211829
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/28/2018

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: 11/30/2019
• Device Catalogue Number: S-60-100-120-P6
• Device Lot Number: 7121161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1