MAUDE Adverse Event Report: ABBOTT VASCULAR OMNILINK ELITE; PERIPHERAL STENT DELIVERY SYSTEM

Catalog Number	1012629-29
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.Visual analysis was performed on the return device.The reported stent dislodgement was confirmed.The failure to advance could not be tested due to the condition of the returned device.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 identified no other incidents and/or complaints from this lot.Based on the information provided, the reported difficulties appear to be due to procedural circumstances.It is likely that after the failed attempt to advance due to resistance with the anatomy, the stent became damaged and loosened on the balloon resulting in dislodgement as the bess was being withdrawn into the introducer sheath.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.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 the procedure was performed to treat a moderately tortuous and heavily calcified lesion in the right common iliac artery.A 6.0x29mm otw omni elite balloon expandable stent system (bess) was being advanced; however, failed to cross due to resistance with the anatomy.The bess was removed from the patient anatomy without resistance.Once the bess was outside the patient anatomy it was noted that the stent was missing.The stent was located inside the distal tip of the 6f sheath.The sheath was removed with the stent in it.The procedure was successfully completed with a new 6f sheath and a 7x27mm unspecified non-abbott stent.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: OMNILINK ELITE
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9405597
• Report Number: 2024168-2019-14074
• Device Sequence Number: 3232310
• Product Code: NIO
• UDI-Device Identifier: 08717648179525
• UDI-Public: 08717648179525
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: 06/30/2020
• Device Catalogue Number: 1012629-29
• Device Lot Number: 7011841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 64