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

Catalog Number 11013-39

Device Problems Difficult to Insert (1316); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat iliac artery stenosis.The 10x39 mm omnilink elite stent delivery system (sds) was attempted to be inserted into a 6fr sheath as it is shown on the box of the device; however, there is significant resistance with the sheath.The physician expressed dissatisfaction as the abbott website shows a 10 mm device should use a 7fr sheath but this is not reflected on the box.Therefore, an 8fr sheath was used and the sds was able to be inserted and then implanted without issue.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation.The investigation determined that the reported difficulties may be the result of using an undersized introducer sheath and inadvertently navigating to the united states website vs.International website for sheath compatibility references.This case took place in india and therefore any website inquiries should be directed to the ¿international¿ website https://www.Cardiovascular.Abbott/int/en/hcp/products/peripheral-intervention/peripheral-stents/omnilink-elite-vascular.Html rather than the united states website.When reviewing the international website for omnilink the 10 mm x 39 mm with the ¿stent sizes and specifications¿ table the ¿sheath compatibility¿ is stated as ¿6 f¿.This french size recommended matches the label on the device in question.It appears that, when searching for the abbott omnilink website information, the united states website was navigated to, where the same omnilink 10 mm x 39 mm size listed in the ¿stent sizes and specifications¿ table shows a ¿sheath compatibility¿ of ¿7 f¿.While this may initially be interpreted as incongruous, it should be noted that abbott is subject to regional regulatory guidance which can lead to slight differences in language across products / websites based on the regulatory agency guidance.Therefore, in this situation, the likely root cause of the reported labelling discrepancy is that the incorrect website was referenced.As to the difficulty in device delivery through a 6f introducer sheath, the investigation determined that the reported difficulties may be the result of using an undersized introducer sheath.There was no information reported regarding the manufacturer information as related to the id of the introducer sheath that the device was initially attempted to be delivered in.On the omnilink packaging label the user is advised to confirm the id of the introducer sheath prior to device insertion using the reference measurements of ¿id 0.087¿ / 2.20 mm.These reference measurements are critical in that id measurements can vary across manufacturers while still being labeled as ¿6 f¿.On the international website, the following footnote is provided below the ¿stent sizes and specifications¿ table under the ¿max crimped o.D.(mm)¿ column: compatible with sheath inner diameters of 2.15 and 2.20 mm for 9 mm x 39 mm, 59 mm and 10 mm x 19 mm, 29 mm, 39 mm stents, respectively.¿ this footnote should be interpreted as emphasizing the minimum id of an introducer sheath by it stating the maximum outer dimeter (od) of the crimped stent.As previously stated, without the data on the id of the introducer sheath used a root cause for this increase in device delivery effort cannot be determined; however a review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event and a review of the complaint history revealed no other similar complaints reported from this lot.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: 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: 18319470
• MDR Text Key: 330676234
• Report Number: 2024168-2023-13946
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 11013-39
• Device Lot Number: 2040442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: .035 HT SUPRACORE GUIDE WIRE; 6FR SHEATH