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

Catalog Number	S-50-060-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
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 analysis.The investigation was unable to determine a conclusive cause for the reported difficulty.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.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.
Event or Problem Description
It was reported that thumb slide worked fine, but the 5.0 x 60 supera stent was difficult to deploy in the predilated, 5 mm diameter, superficial femoral artery.The physician moved the thumb slide back and forth until the stent was eventually completely released.It was released completely within its target area.There were no adverse patient effects and 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: 6099840
• Report Number: 2024168-2016-07927
• Device Sequence Number: 10836471
• Product Code: NIP
• UDI-Device Identifier: 08717648211744
• UDI-Public: (01)08717648211744
• 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): 11/14/2016

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 Catalogue Number: S-50-060-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2016
• Initial Report FDA Received Date: 11/14/2016
• 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: SHEATH: 6FR 40CM BULKEN
• Patient Age: 76 YR