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

Model Number	1012632-29
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.The second ominilink elite device referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that this was a percutaneous intervention to treat the bilateral iliac arteries.When the 9.0x29 mm omnilink elite was being removed from the packaging hoop, the stent fell off of the stent delivery system on the back table; there was no patient involvement.Another 9.0x29 mm omnilink elite was prepared and inserted into the 6 french sheath, but was not able to come out of the sheath to use in the patient.The sheath had to be removed from the patient so the omnilink elite could be removed from the sheath.A new 6 french sheath of the same brand was used in the patient with two 8.0x29 omnilink elite stents without further incident.The physician felt that the first two omnilink elite stents were not crimped on the balloon delivery system properly.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device and the reported stent dislodgement was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incidents there is no indication of a lot specific product quality issue.As there were visible crimp marks noted on the balloon between the markers this suggests the stent was originally positioned correctly and securely at the time of manufacture.The investigation determined the stent dislodgement appears to be related to circumstances of the procedure, as it is likely that inadvertent mishandling and/or forced sheath removal during unpackaging resulted in the reported stent dislodgement.The noted stent damages likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture.

• 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: 12136225
• Report Number: 2024168-2021-05830
• Device Sequence Number: 19066625
• Product Code: NIO
• UDI-Device Identifier: 08717648178542
• UDI-Public: 08717648178542
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 07/31/2024
• Device Model Number: 1012632-29
• Device Catalogue Number: 1012632-29
• Device Lot Number: 1020441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 57