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

Catalog Number 1012622-19

Device Problems Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure to treat a calcified, stenosed lesion in the iliac artery, a 6.0x19 mm omnilink elite stent system was advanced without resistance and inflated; however, the balloon failed to inflate.A leak was suspected.The stent system was simply withdrawn from the patient anatomy and a new same sized omnilink stent system was advanced and the stent was implanted without issue.An 8.0x20 mm armada 35 percutaneous transluminal (pta) catheter was advanced without resistance for post-dilatation as standard procedure and the balloon failed to inflate.A leak was suspected.The armada 35 pta catheter was simply withdrawn from the patient anatomy and a new same sized armada 35 pta catheter was successfully used for post-dilation.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The armada 35 device referenced is being filed under a separate medwatch report.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other similar incidents for inflation issue or leak reported from this lot.Based on the reviewed information, no product deficiency was identified.

• 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4459751
• MDR Text Key: 16539341
• Report Number: 2024168-2015-00419
• Device Sequence Number: 1
• Product Code: NIO
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/15/2015

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 Expiration Date: 04/30/2017
• Device Catalogue Number: 1012622-19
• Device Lot Number: 3112541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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