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

Catalog Number	S-50-100-120-P6
Health Effect - Clinical Codes	Embolism (1829); Thrombosis (2100)
Date of Event	05/09/2018
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 analysis.It is likely that operational context of the procedure contributed to the reported difficulties.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 reported patient effects of embolism, thrombosis and surgery are listed in the supera instructions for use (ifu) as known patient effects associated with the use of the device.The investigation determined the reported difficulties, subsequent patient effects, additional treatment and removal of the device and surgery appear to be related to case circumstances.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other supera stent is filed under a separate manufacturer report number.
Event or Problem Description
It was reported that following pre-dilatation with a 5.0 balloon catheter for 2-3 minutes, a 4.5 supera stent was implanted in the distal popliteal lesion and following a 5.0 supera stent was implanted more proximal with some overlap.Both stents were implanted without issue with reported perfect results and both were well apposed to the vessel wall.Following, a thrombus was observed within the stents with total occlusion.The thrombus then embolized distally and a 6f catheter was used in attempt to retrieve the thrombus.During removal of the catheter through the stents, reportedly the operator did not visualize the sheath during removal and the sheath caught the 5.0 supera stent and elongated the 5.0 stent.The stents remained well apposed to the vessel wall.On (b)(6) 2018, a bypass was performed, leaving the supera stents within the patients anatomy.The patient is in stable condition without further issues reported.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: 7565670
• Report Number: 2024168-2018-04093
• Device Sequence Number: 13892828
• Product Code: NIP
• UDI-Device Identifier: 08717648211768
• UDI-Public: 08717648211768
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P120020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: 10/31/2019
• Device Catalogue Number: S-50-100-120-P6
• Device Lot Number: 7110961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/04/2018
• 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: 1 IMPLANTED SUPERA STENT
• Outcome Attributed to Adverse Event: Required Intervention; Disability