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

Catalog Number 1012630-29

Device Problems Inflation Problem (1310); Material Rupture (1546); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a re-stenosed lesion in the right external iliac artery with no tortuosity and no calcification.A 7.0 x 29 mm omnilink elite stent delivery system (sds) was advanced to the lesion; however, there was no pressure increase on the inflation device and the balloon of the sds failed to inflate.The same issue occurred when trying a different inflation device.The stent failed to deploy and the sds was simply removed.A new 7.0 x 29 mm omnilink elite sds was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The reported difficulties were not confirmed.The returned unit was inflated to 14 atmospheres with no anomalies noted.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 from this lot.The investigation was unable to determine a cause for the he reported difficulties.It may be possible that the connection between the inflation device and omnilink elite luer was not properly connected or the inflation device was not working properly; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 8175125
• MDR Text Key: 130797165
• Report Number: 2024168-2018-09801
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1012630-29
• Device Lot Number: 6120541
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/14/2018
• Date Manufacturer Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1