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

Model Number	S-55-080-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 was unable to determine a conclusive cause for the reported tip detachment.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling; therefore, no corrective action is required.
Event or Problem Description
It was reported that the procedure was to treat a right superficial femoral artery.The 5.5x120 cm supera stent was successfully deployed, however during removal of the supera stent system; the tip separated in the patient anatomy.A snare device and safety net were used to successfully retrieve the tip.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Corrections: date of event, date of relevant tests, implant date.(b)(4).
Event or Problem Description
Subsequent to the previously filed medwatch report, a medsun report was received stating: a supera 5.5x80mm stent was deployed into the patient's superficial femoral artery (sfa).Three (3) more zilver stents were deployed and then small segment of wire visualized on angiogram.It was thought that the nose cone of the supera that had become detached from the tip of the stent.The stent appeared to be deployed correctly.A snare wire was deployed, the wire and nose cone was captured in the snare and pulled through the sheath.The sheath was cut and the wire dragged out.The sheath was exchanged over wire for new 6 ansel sheath.No harm to patient aside from increased radiation time.

• 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: 6653423
• Report Number: 2024168-2017-05193
• Device Sequence Number: 13835604
• Product Code: NIP
• UDI-Device Identifier: 08975370026306
• UDI-Public: (01)08975370026306(17)190131(10)7022361
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Followup
• Report Date (Section B): 07/11/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: S-55-080-120-P6
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 7022361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 07/07/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR