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

Model Number	1012625-59
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 complaints.It should be noted that the omnilink elite instruction for use (ifu) lists, introducer sheath / guiding catheter in the appropriate size and configuration for the selected stent delivery system.The ifu indicates that a 9.0mm stent requires a recommended minimum introducer sheath of 7fr.Additionally, the product label for this device lists recommended minimum inner diameter introducer sheath of 7fr, 2.33mm (0.092¿).The undersized introducer sheath likely contributed to the reported difficulties.Based on the information provided, the reported difficulties resulting in stent dislodgment and foreign body in patient appear to be due to an inadvertent use error.The resistance encountered during advancement was due to inadvertently using an undersized introducer sheath.Additionally, it is likely that advancing through the sheath against resistance caused the stent to become compromised on the balloon resulting in dislodgment of the stent into the right common iliac artery.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.(b)(4).
Event or Problem Description
It was reported this was a procedure to treat a mildly calcified left common iliac artery.An omnilink elite 9mm/59mm/80cm stent was inserted.However, it was noted the physician used a 6fr sheath rather than a 7fr sheath.It was noted that due to the size of the sheath, slight resistance was felt during advancement.It was then observed the stent dislodged from the balloon and was deployed in the right common iliac artery.The stent remained in place; therefore, no treatment was performed to for removal.The 6fr sheath was removed and replaced with a 7fr sheath.An additional omnilink stent was inserted and successfully deployed at the intended site.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Common Device Name: PERIPHERAL STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12436413
• Report Number: 2024168-2021-07930
• Device Sequence Number: 3585632
• Product Code: NIO
• UDI-Device Identifier: 08717648179358
• UDI-Public: 08717648179358
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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: 05/31/2024
• Device Model Number: 1012625-59
• Device Catalogue Number: 1012625-59
• Device Lot Number: 0121441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/07/2021
• 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: Other
• Patient Age: 73 YR
• Patient Weight: 93