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

Catalog Number 11003-59

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.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 reported from this lot.The reported patient effect of infection is listed in the electronic instructions for use peripheral stent system omnilink elite, ce as a known patient effect of coronary stenting procedures.There was no damage noted to the sds during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported failure to advance, difficulty to advance, difficulty to remove and stent dislodgement appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture.

Event Description

It was reported that the procedure was to treat a subclavian artery.A 7x59mm omnilink elite stent delivery system was being advanced to the lesion but failed to cross due to resistance met with the anatomy and the introducer sheath.During removal, resistance with the introducer sheath was met and the stent dislodged distally to the introducer tip.A cut-down surgery was performed to extract the stent.Another unspecified stent was then implanted to successfully completed the procedure.Several days later, a surinfection was noted at the surgical site and treated via medication, which the physician deems as a clinically significant delay.The patient is in good condition.It is unknown how long the patient remained in the hospital and the discharge date.No additional information was provided.

• 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: 10567566
• MDR Text Key: 207960025
• Report Number: 2024168-2020-07896
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 11003-59
• Device Lot Number: 9082241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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: 6F TERUMO INTRODUCER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention