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

Catalog Number	S-60-040-120-P6
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed no other similar incidents reported from this lot.The investigation was unable to determine a cause for the reported deployment difficulty.The stent elongation, tip detachment and additional treatment to remove the tip appears to be due to circumstances of the procedure.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 a procedure on (b)(6) 2016, the supera stent delivery system (sds) was advanced to the moderately calcified, moderately tortuous, right superficial femoral artery (sfa), where the stent was successfully deployed.During removal of the sds, the tip caught on the deployed stent, elongating the stent and pulling it to the right iliac artery, where it remained.Additionally, the tip detached from the sds.A snare device was used and the detached white tip was removed from the anatomy without issue.After angiography the vessel looked good and no further intervention was performed.There was no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Patient weight, rounded; actual weight (b)(6).
Event or Problem Description
Subsequent to the initial 30-day medical device report, a voluntary report was received which states: patient had peripheral vascular disease with claudication of the lower extremity.During percutaneous transluminal angioplasty (pta) of the right superficial femoral artery, the nose cone [tip] of the stent broke off.Consult done with vascular surgeon, who recommended an endovascular procedure to remove the retained broken piece of stent.What was the original intended procedure? pta of right superficial femoral artery device usage problem: device malfunction - that is, the device did not do what it was suppose to do.

• 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: 6031146
• Report Number: 2024168-2016-06953
• Device Sequence Number: 13563314
• Product Code: NIP
• UDI-Device Identifier: 08717648211799
• UDI-Public: (01)08717648211799(17)170831(10)5090361
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 11/03/2016

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: S-60-040-120-P6
• Device Lot Number: 5090361
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 11/03/2016
• 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: 81 YR
• Patient Weight: 78