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

Model Number	S-50-080-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported deployment issue was unable to be confirmed as the stent had already been fully deployed.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 of the reported lot revealed no other incidents.It should be noted that the supera instruction for use (ifu) instructs: while maintaining increased magnification from step 3, rotate the deployment lock to the unlocked position.Under fluoroscopy, slowly advance the thumb slide to the distal most position on the handle.Confirm under fluoroscopy that the entire supera stent has emerged from the outer sheath and is released.The investigation was unable to determine a cause for the reported difficulty.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 located in the popliteal artery that was heavily tortuous.Following pre-dilatation, a supera peripheral self expanding stent (ses) 5.0 x 80 6f 120 cm was deployed.It was thought that the entire stent had completely come out of the sheath, however it did not detach and when the deployment system was removed from the anatomy, the stent came with it.It was reported that the delivery system was not removed under fluoroscopy.Another supera ses was used to complete the procedure.There was no reported adverse patient effect.There was no reported 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: 6714410
• Report Number: 2024168-2017-05899
• Device Sequence Number: 919849
• Product Code: NIP
• UDI-Device Identifier: 08717648211751
• UDI-Public: (01)08717648211751(17)180930(10)6102061
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 07/14/2017

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 Expiration Date: 09/30/2018
• Device Model Number: S-50-080-120-P6
• Device Catalogue Number: S-50-080-120-P6
• Device Lot Number: 6102061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1