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

Catalog Number 1012624-29

Device Problems Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned to abbott vascular for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents reported for the lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.During advancement, the introducer sheath met resistance with the previously implanted stent causing the stent to buckle and/or deform resulting in the implanted stent to move from the deployed position.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat a target lesion in the left common iliac artery.The 8.0 x 29 mm omnilink elite stent delivery system was implanted in the left common iliac artery.The stent was well apposed to the vessel wall and everything looked good.The physician decided to advance a sheath through the newly implanted stent, to evaluate the distal vessel for additional lesions/intervention.The sheath had resistance advancing through the stent and caused the stent to buckle and move from its original position.The sheath was removed and a dilatation catheter was advanced.Additional ballooning was able to treat the buckling.As the stent had moved from its original location, an additional 8.0 x 29 mm omnilink elite stent was implanted at the proximal lesion to cover the lesion that was uncovered when the stent moved.The patient was in stable condition post procedure.There were no adverse patient sequelae and no clinically significant delay.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: 7856544
• MDR Text Key: 119565755
• Report Number: 2024168-2018-06962
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08717648179297
• UDI-Public: 08717648179297
• 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: 09/07/2018

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: 12/31/2020
• Device Catalogue Number: 1012624-29
• Device Lot Number: 7071041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2017
• 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
• Patient Age: 61 YR