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

Catalog Number	1012623-59
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat the heavily calcified, moderately tortuous, 90% stenosed external iliac artery.The patient was going to have a right common femoral endarterectomy as well and this was performed first without issue.Then a 6fr sheath was placed through the patch on the ipsilateral side and an.035 supra core guide wire was used.No pre-dilatation was performed and the 7x100 mm absolute pro self expanding stent system (sess) was advanced to the lesion.Deployment was attempted and the thumbwheel was rolled completely until it stopped; however, the stent only deployed 1 cm.The delivery system and stent were then pulled down to the site of the endarterectomy, and resistance was noted with the vessel.The device was attempted to be removed but the stent elongated significantly across the target lesion.The elongated stent was cut and part was left in situ.Next, a 7x59 mm omnilink elite stent delivery system was advanced to the lesion and significant resistance was felt so it was decided to remove the device.The omnilink elite sds only partially reached the lesion due to resistance with the anatomy.In removing the device, the stent came completely off of the balloon and was retrieved through the endarterectomy site with a pair of long angled forceps.The groin was then closed and no further stenting was attempted.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional absolute pro device referenced in b5 is captured under a separate medwatch number.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stent dislodgement was confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory in addition 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.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure, as it is likely the device interacted with the heavily calcified, moderately tortuous, 90% stenosed lesion during advancement, as significant resistance was noted, resulting in the reported failure to advance.Further interaction with the challenging anatomy during retraction of the device, as resistance was again noted, likely contributed to the reported stent dislodgement.In removing the device, the stent came completely off the balloon and was retrieved through the endarterectomy site with a pair of long angled forceps.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that the procedure was to treat the heavily calcified, moderately tortuous, 90% stenosed external iliac artery.The patient was going to have a right common femoral endarterectomy as well and this was performed first without issue.Then a 6fr sheath was placed through the patch on the ipsilateral side and an.035 supra core guide wire was used.No pre-dilatation was performed and the 7x100 mm absolute pro self expanding stent system (sess) was advanced to the lesion.Deployment was attempted and the thumbwheel was rolled completely until it stopped; however, the stent only deployed 1 cm.The delivery system and stent were then pulled down to the site of the endarterectomy, and resistance was noted with the vessel.The device was attempted to be removed but the stent elongated significantly across the target lesion.The elongated stent was cut and part was left in situ.Next, a 7x59 mm omnilink elite stent delivery system was advanced to the lesion and significant resistance was felt so it was decided to remove the device.The omnilink elite sds only partially reached the lesion due to resistance with the anatomy.In removing the device, the stent came completely off of the balloon and was retrieved through the endarterectomy site with a pair of long angled forceps.The groin was then closed and no further stenting was attempted.There were no adverse patient sequela.Subsequent to the initially filed mdr report it was reported that the portion of the absolute pro stent which remained in the anatomy covered the target lesion and the stent was cut with heavy duty surgical scissors.The sheath of the device was separated; however, the account was not aware of the separation.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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 18132217
• Report Number: 2024168-2023-12617
• Device Sequence Number: 15110235
• Product Code: NIO
• UDI-Device Identifier: 08717648179273
• UDI-Public: 08717648179273
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: 12/31/2024
• Device Catalogue Number: 1012623-59
• Device Lot Number: 1071341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR SHEATH; SUPRA CORE GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown