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

Model Number	1012624-39
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
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 the right common iliac artery with 50% stenosis.A 6fr sheath was entered into the left common femoral access site and a viperwire which was used with a non-abbott atherectomy device was already present at the target lesion.The 8x39 mm omnilink elite stent delivery system (sds) was advanced on the guide wire but there was resistance at the sheath and the device could not be advanced.There was some resistance at the sheath during removal and the stent elongated.A new non-abbott guide wire and non-abbott stent were used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported stretched stent was not confirmed.The reported difficult to advance and difficult to remove could not be tested due to the condition of the returned device.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.The investigation was unable to determine a conclusive cause for the reported difficult to advance/position and difficult to remove.As the reported stretched stent could not be confirmed during returned device analysis testing, it is likely the account was referring to the observed material deformation (bent, overlapping, and stretched struts).Factors which may contribute to difficulty advancing and removing the device in the introducer sheath include, but are not limited to, damage to the stent, damage to the introducer sheath / guiding catheter, sheath/guiding catheter size selection or procedural technique (devices not properly supported or coaxially aligned).In this case, it may be possible that the inner diameter of the introducer sheath was smaller than the recommended diameter of 0.085 inches (2.15 mm) indicated on the omnilink elite product label.It should be noted that there is no specific industry definition of 6f introducer sheath / guide catheter dimensions or what it means to have a product that is 6f compatible.The only guidance the sheath producers have is to make the inner diameter larger than 2.00mm and smaller than 2.33mm.This contrasts with the convention for guiding catheters that have a clear definition of a maximum outer diameter of 2.0mm.The lack of clear industry guidance may be a contributing factor to why there is a broad range of inner diameters found in commercial introducer sheaths.In addition, it is likely the device interacted with the introducer sheath during advancement, as resistance was noted, causing the observed bunched and smashed inner/outer member.Further interaction with the introducer sheath during retraction of the device, as resistance was again noted, likely contributed to the observed material deformation, ultimately causing the observed stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Additional information: d4 - model # added.Corrections: d1 - brand name updated.D2a - common device name updated.D3 - name updated.D3 - address, city, postal code 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: 19548815
• Report Number: 2024168-2024-07265
• Device Sequence Number: 4850856
• Product Code: NIO
• UDI-Device Identifier: 08717648179303
• UDI-Public: (01)08717648179303(17)261031(10)3051541
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/16/2024

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 Model Number: 1012624-39
• Device Catalogue Number: 1012624-39
• Device Lot Number: 3051541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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: UNSPECIFIED ATHERECTOMY DEVICE; VIPERWIRE
• Patient Age: 70 YR
• Patient Sex: Male