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

Catalog Number	S-55-100-120-P6
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Claudication (2550)
Date of Event	08/07/2018
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.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the lot number was not reported.Claudication is listed in the supera instructions for use as known potential patient effect associated with the use of the device.The investigation was unable to determine a cause for the reported material deformation and subsequent patient effects.It may be possible that the location of the proximal end of the stent in the popliteal resulted in severe torquing or kinking of stent (material stress/ fatigue) causing the proximal end to appear crushed.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 performed on (b)(6) 2017 was to treat a lesion with moderate calcification in the proximal popliteal and distal superficial femoral artery.A 5.5 x 100 mm supera stent was implanted successfully.On (b)(6) 2018, the patient was experiencing claudication.Angiography revealed that the proximal end of the supera stent was crushed.On (b)(6) 2018, the patient was treated with laser atherectomy, ballooning and another supera stent was implanted at the proximal popliteal, proximal of the supera implant angiography confirmed good results.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: 7799174
• Report Number: 2024168-2018-06382
• Device Sequence Number: 2076154
• Product Code: NIP
• UDI-Device Identifier: 08717648226120
• UDI-Public: 08717648226120
• 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
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2018

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 Catalogue Number: S-55-100-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 08/20/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 64 YR