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

Catalog Number	1012631-19
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual inspection was performed on the returned device.The stent dislodgment was confirmed.The failure to advance 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.It should be noted that the omnilink elite instruction for use (ifu) states: do not attempt to pull an unexpanded stent back through the introducer sheath; dislodgement of the stent from the balloon may occur.The investigation determined that the reported difficulties were due to case circumstances.In this case, the failure to advance was due to anatomical conditions.However, the dislodgment likely occurred due to removing and re-inserting the device multiple times.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 a tortuous iliac vessel with moderate calcification.The omnilink elite stent delivery system (sds) attempted to cross the moderately calcified lesion, however, would not advance due to anatomy.The device was removed without issue and the patient was re-wired with a stiffer wire.The same omnilink elite sds was re-inserted and again failed to cross the lesion due to anatomy.The device was removed without issue and balloon angioplasty was performed at the lesion site.The same omnilink elite sds was re-inserted for a third time, and again failed to cross the lesion.During sds removal, the stent dislodged from the sds, due to anatomy, in a completely unintended area, the mid iliac.As treatment, additional balloon angioplasty was performed within the stent, apposing the stent to the vessel wall.Another device was used to treat the lesion.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: 7856934
• Report Number: 2024168-2018-06967
• Device Sequence Number: 11097329
• Product Code: NIO
• UDI-Device Identifier: 08717648178498
• UDI-Public: 08717648178498
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 07/31/2021
• Device Catalogue Number: 1012631-19
• Device Lot Number: 8021241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/07/2018
• 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: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 81