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	Occlusion (1984)
Date of Event	12/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of occlusion is listed in the supera instructions for use as a known patient effect of peripheral stenting procedures.Based on the case information and related record review, a conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue.The 6.0x150 supera is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that intravascular ultrasound (ivus) was performed in the superficial femoral artery (sfa) before the procedure.The sfa was prepared with atherectomy and a 6.0x100 balloon dilatation catheter.Two supera stents, sizes 6.5x150 and 6.0x150 were implanted in the sfa.Ivus confirmed good blood flow in the stent as well as good flow proximal and distal to the stent.90 minutes after the stent procedure, the patient was noted to have asymptomatic diminished pulse volume recording (pvr).Ultrasound found both stents had occluded.No additional medication and no additional treatment was performed.The patient was discharged home the same day.The patient will be re-assessed for treatment at a later date.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: 6167646
• Report Number: 2024168-2016-08803
• Device Sequence Number: 730411
• Product Code: NIP
• UDI-Device Identifier: 08975370026399
• UDI-Public: (01)08975370026399(17)180430(10)6050661
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 6050661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2016
• Initial Report FDA Received Date: 12/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 6.0X150 SUPERA STENT
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Weight: 125