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

Catalog Number	S-45-100-120-P6
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2016
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.(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.
Event or Problem Description
It was reported that the procedure was to treat a long segment chronic total occlusion located in the severely calcified/fibrosed superficial femoral artery.The vessel diameter was 5 mm and was pre-dilated using a 5 mm balloon at high pressure.The 4.5 x 100 mm supera stent delivery system (sds) was advanced to the lesion; however, after deployment of the stent for about 5 mm it stopped deploying due to the deployment mechanism jamming.Retraction of the stent delivery system was performed using angiography.During retraction of the stent delivery system the tip of the catheter separated; however, the sheath with the stent inside and tip were able to be removed leaving nothing in the patient.Another stent was used to complete the case.There was no adverse patient effects or clinically significant delay in the procedure reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis and abbott vascular (av) was unable to confirm the reported issue due to the condition of the device.The device was returned with the outer member separated at the distal end of the strain relief tubing.The complaint handling database was reviewed and there were no similar events for this lot.Root cause analysis concluded that the issue may be due to manufacturing.The results of the investigation, concludes that the appropriate process controls are in place in manufacturing to detect this failure mode.Av will continue to trend the performance of these devices.

• 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: 6100989
• Report Number: 2024168-2016-07948
• Device Sequence Number: 827310
• Product Code: NIP
• UDI-Device Identifier: 08975370026269
• UDI-Public: (01)08975370026269(17)180331(10)6040761
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 04/10/2017

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: 03/31/2018
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 6040761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 04/10/2017
• 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: 4.5 X 120 OSCOR DESTINO
• Patient Age: 71 YR