MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number	1012630-29
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.(b)(4).The device was not returned for analysis.The investigation determined that the reported stent dislodgement was user related.The failure to advance and additional treatment was due to case circumstances.It should be noted that the omnilink elite peripheral stent system instructions for use states: do not attempt to pull an unexpanded stent back through the introducer sheath; dislodgement of the stent from the balloon may occur.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.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 supera stent referenced 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: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6111335
• Report Number: 2024168-2016-08054
• Device Sequence Number: 748075
• Product Code: NIO
• UDI-Device Identifier: 08717648178467
• UDI-Public: (01)08717648178467(17)181130(10)5060541
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• 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 Expiration Date: 11/30/2018
• Device Catalogue Number: 1012630-29
• Device Lot Number: 5060541
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 5.5X150 SUPERA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 86