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

Model Number	1012631-39
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a lesion in the right common iliac artery.The 8.0x39mm otw omnilink elite stent delivery system (sds) was advanced into the patient anatomy however it was noted the stent had started to dislodge from the balloon as it was caught in the calcium.The sds was pulled back although resistance was met with the 7fr sheath and the stent came off the balloon even more.The physician decided the best option was to deploy it in a healthy vessel in the left common iliac.Another omnilink elite was then successfully deployed in the target lesion.There were no adverse patient sequela and no clinically significant delay in 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 did not indicate a lot specific quality issue.A conclusive cause for the reported difficulties could not be determined; however, the subsequent serious injury/ illness/ impairment and foreign body in patient appear to be related to the operational context of the procedure.Factors that could contribute to failure to advance include, but are not limited to, patient anatomical morphology, patient disease state, pre-dilatation strategy, device placement technique, interaction with previously placed stents or accessory devices.Factors that can contribute to difficult to remove include, but are not limited to, guiding catheter lumen obstructions, interaction with the anatomy, kinks, bends, procedural technique, insufficient support, or interactions with other devices.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, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with the anatomy, or interaction with accessory devices.In this case, it is possible the device may have interacted with the calcified lesion during advancement, resulting in the reported failure to advance.Further interaction with the challenging anatomy in addition to the introducer sheath during retraction of the device, as resistance was noted, may have contributed to the reported difficult to remove, ultimately causing the reported stent dislodgement; however, without the device to examine, this cannot be confirmed.The physician decided the best option was to deploy it in a healthy vessel in the left common iliac.Another omnilink elite was then successfully deployed in the target lesion.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 20009195
• Report Number: 2024168-2024-09713
• Device Sequence Number: 15261547
• Product Code: NIO
• UDI-Device Identifier: 08717648178511
• UDI-Public: (01)08717648178511(17)260831(10)3030341
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P110043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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: 08/31/2026
• Device Model Number: 1012631-39
• Device Catalogue Number: 1012631-39
• Device Lot Number: 3030341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2023
• 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: 7FR SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 72 KG