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

Catalog Number	S-55-120-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported difficulties and treatments appear to be related to circumstances of the procedure.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 in the left superficial femoral artery with moderate calcification.A 5.5x120mm supera self-expanding stent system (sess) was advanced without resistance toward the target lesion.An attempt was made to deploy the stent.The stent flowered but after that was difficult to deploy.Additionally, the stent could not be seen.Reportedly a previously implanted stent was in the way.The physician attempt to remove the device from the patient anatomy and the supera stent became elongated around the horn.The physician pushed the stent up into the aorta and the stent opened up.A snare device was used to successfully retrieve the stent from the patient anatomy.The lesion was ultimately treated using an unspecified balloon and a non-abbott stent.There was a delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Attachment: user facility medwatch report number (b)(4).The part number on the medsun report is (b)(4), which is different than the reported part number of (b)(4).It was confirmed that the correct part number was the original reported part number of (b)(4).(b)(4).
Event or Problem Description
Subsequent to the final mdr report a medsun mandatory and voluntary report # (b)(4) states: according to physician while attempting to deploy, the stent was unable to deploy.While removing, the stent was partially open and got caught on existing stents which pulled the stent off device.The stent was then sitting in the aorta area and had to be removed, stent was removed after a few unsuccessful attempts.No patient harm.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: 6215861
• Report Number: 2024168-2016-09397
• Device Sequence Number: 10857266
• Product Code: NIP
• UDI-Device Identifier: 08975370026320
• UDI-Public: (01)08975370026320(17)180331(10)6042661
• 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
• 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): 03/02/2017

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: 03/31/2018
• Device Catalogue Number: S-55-120-120-P6
• Device Lot Number: 6042661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 03/02/2017
• 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