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

Catalog Number	1012631-29
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2018
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.(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no similar incidents.The omnilink elite instructions for use (ifu) states, do not attempt to pull an unexpanded stent back through the introducer sheath / guiding catheter; dislodgment of the stent from the balloon may occur.The investigation was unable to determine a conclusive cause for the reported resistance with the introducer sheath.It may be possible that the sheaths used were not the appropriate inner diameter (id); however, the omnilink elite and sheath were not returned for analysis.Therefore, the exact inner diameter is unknown.In this case, the resistance with the sheath was the likely cause for the dislodgment.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 during a procedure of the calcified, right iliac artery the 8 x 29 mm omnilink elite stent delivery system (sds) was advanced through the 6 fr non-abbott sheath but met resistance and became stuck.The sds could not be advanced or removed separately; all devices were being removed from the anatomy as a system when the stent implant dislodged off the balloon into the anatomy.A cutdown procedure was used to successfully remove the stent from the anatomy without adverse patient sequela.A different stent was used in the procedure without issue.The patient was reported in good condition.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: 8005227
• Report Number: 2024168-2018-08174
• Device Sequence Number: 16469270
• Product Code: NIO
• UDI-Device Identifier: 08717648178504
• UDI-Public: 08717648178504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/25/2018

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: 09/30/2019
• Device Catalogue Number: 1012631-29
• Device Lot Number: 6041441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 10/25/2018
• 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: 6 FR TERUMO DESTINATION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 79