MAUDE Adverse Event Report: ABBOTT VASCULAR INC. OMNILINK ELITE; STENT, ILIAC

Model Number	1012622-39
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right superficial femoral artery (sfa) with heavy calcification.The 6x39mm omnilink elite balloon expanding stent (bes) was being advanced through the target lesion with resistance due to the anatomy.The bes could not completely cross the lesion; therefore, the bes was removed from the patient and when the stent shaft was removed from the sheath the stent was noted to not be on the balloon.Angiography found that the stent was in the right iliac artery.Therefore, the balloon of the delivery system was re-advanced through the stent struts and the stent was deployed in the right external iliac artery.An armada balloon was then used to further dilate the stent.There was no adverse patient sequela.Another stent was implanted at the target lesion to complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other complaints.Difficult to advance/position may be attributed to several factors including, but are not limited to, product placement technique, guiding catheter support, inner diameter of guide wire lumen, outer diameter of the guide wire, patient morphology, condition of the guide wire, interaction with accessory devices, damage to the catheter or accumulation of blood or contrast.Stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, forced sheath removal, anatomical conditions, handling of the stent during preparation, and interaction with accessory devices.In this case, it is possible that interaction with the heavily calcified lesion during advancement, as resistance was noted, may have contributed to the reported difficult to advance/position.Further interaction with the challenging anatomy during retraction of the device may have contributed to the reported stent dislodgement in the right iliac artery; however, this cannot be confirmed.A conclusive cause for the reported difficulties could not be determined; however, the subsequent unexpected medical intervention and device embedded in tissue or plaque appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D1 correction: brand name updated d2a correction: common device name updated d3 correction: name, address updated.

• Brand Name: OMNILINK ELITE
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19579683
• Report Number: 2024168-2024-07446
• Device Sequence Number: 3980370
• Product Code: NIO
• UDI-Device Identifier: 08717648179204
• UDI-Public: (01)08717648179204(17)250228(10)1092141
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 02/28/2025
• Device Model Number: 1012622-39
• Device Catalogue Number: 1012622-39
• Device Lot Number: 1092141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown