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

Catalog Number	S-55-150-120-P6
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	11/03/2016
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.Estimated implant date.The device was not returned for analysis.The investigation determined the reported twisted/distorted stent and additional patient effects are due to circumstances of the procedure.The reported patient effects of occlusion and pain are listed in the supera instructions for use as known potential patient effects associated with use of the device.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the lot number was not reported.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.The omnilink elite referenced in describe event or problem is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the 5.5x150 supera stent had become twisted, telescoped from movement of the superficial femoral artery (sfa) when the patient was walking and the patient had leg pain.The 7.0 x 29 omnilink elite stent delivery system (sds) was inserted to help straighten out the vessel to allow another supera to be deployed in the sfa, but the sds interacted with the occluded supera stent.The sds was removed and the supera was balloon dilated.The omnilink sds was re-inserted, but the omnilink stent dislodged from the sds balloon.The sds was used to push the dislodged stent as far down as they could get it and the omnilink stent was deployed with a 4.0x100 non-abbott balloon.The omnilink sds was re-inserted and inflated for post dilatation.Another supera was implanted, as planned, to treat the occluded 5.5x150 supera.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: 6111336
• Report Number: 2024168-2016-08055
• Device Sequence Number: 1123713
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: (01)08975370026337
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 11/17/2016

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-55-150-120-P6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 11/17/2016
• 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: 57 YR
• Patient Weight: 86