MAUDE Adverse Event Report: AV-TEMECULA-CT OMNILINK ELITE PERIPHERAL STENT SYSTEM

Catalog Number 1012630-39

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

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 03/13/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 similar incidents reported from this lot.The investigation determined the reported difficulties of failure to advance, difficult to remove and stent dislodgement appear to be related to circumstances of the procedure.Based on the reported information, during advancement the sds encountered resistance with the mildly tortuous and moderately calcified anatomy causing the reported failure to advance and difficulty to remove.Manipulation of the device against resistance during retraction resulted in the stent dislodgement.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a mildly tortuous and moderately calcified lesion in the common iliac artery.The vessel was not pre-dilated.A 7.0x39mm omnilink elite otw stent delivery system (sds) was advanced but would not cross the target lesion.The sds then became stuck with the anatomy and the stent dislodged from the balloon in the common iliac artery.The sds was removed, and another omnilink sds was then advanced and the stent was deployed to crush the dislodged omnilink stent into the vessel wall, within the target lesion, and the procedure concluded.There was no adverse patient sequela, and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: OMNILINK ELITE PERIPHERAL STENT SYSTEM
• Type of Device: PERIPHERAL STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8514246
• MDR Text Key: 141932784
• Report Number: 2024168-2019-02906
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648178474
• UDI-Public: 08717648178474
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/15/2019

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: 07/31/2021
• Device Catalogue Number: 1012630-39
• Device Lot Number: 8022341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Patient Outcome(s): Required Intervention