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

Catalog Number	1012629-59
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2019
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.Evaluation summary: visual and functional inspection was performed on the returned device.The dislodged stent was not confirmed.The stent implant was stationary on the balloon but not between the markers.The failure to advance and difficulty removing was unable to be replicated as it was based on case circumstances.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 revealed no other incidents.The investigation determined that the reported difficulties appear to be due to case circumstances.The failure to advance was likely due to anatomical conditions which were described as heavily calcified.Additionally, after the failed attempt to advance, it is likely that the stent damage occurred during removal due to interaction with the sheath.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 this was a percutaneous intervention treating an iliac artery, heavily calcified lesion.A 6fr sheath was placed left pedal access and a 6.0 omnilink elite stent delivery system (sds) advanced.The sds had failed to cross the heavily calcified iliac lesions due to anatomy.During sds removal, difficulty was noted with the sds within the sheath.The stent dislodged in the sheath.The sheath and sds were removed from the anatomy as a single unit without further issues.Nothing was left inside the anatomy besides the guide wire.Another sheath was placed and procedure continued using another omnilink elite.There were no adverse patient effects and no clinically significant delay.No additional information was provided regarding this issue.

• 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: 8433960
• Report Number: 2024168-2019-02120
• Device Sequence Number: 1650945
• Product Code: NIO
• UDI-Device Identifier: 08717648179549
• UDI-Public: 08717648179549
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/19/2019

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: 11/30/2019
• Device Catalogue Number: 1012629-59
• Device Lot Number: 6061841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/19/2019
• 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: 6F
• Patient Age: 65 YR
• Patient Weight: 64