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

Catalog Number	S-55-150-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/04/2016
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 did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.
Event or Problem Description
It was reported that the procedure was a mildly calcified, restenosed mid superficial femoral artery.Pre-dilatation was performed with a 5.5 x 100 mm armada balloon catheter for 2 inflations for 2 minutes to pre-dilated 150 mm of the lesion.A 5.5 x 150 mm supera stent was successfully deployed.It was confirmed that the stent was completely deployed and away from the sheath.The thumbslide was locked and the device was removed without resistance.Angiography confirmed the stent was fully apposed to the vessel wall.When attempting to post-dilate, it was noted that the stent had elongated from 150 to 250 mm.Post-dilatation was performed with the same 5.5 x 100 mm armada that was used for pre-dilatation to complete the procedure.The patient is doing fine.There was no clinically significant delay in the procedure.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: 6041692
• Report Number: 2024168-2016-07075
• Device Sequence Number: 76317
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: (01)08975370026337(17)180228(10)6031661
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2016

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: 02/28/2018
• Device Catalogue Number: S-55-150-120-P6
• Device Lot Number: 6031661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 10/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 120