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

Catalog Number 1012633-29

Device Problems Inflation Problem (1310); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2015

Event Type  malfunction  

Event Description

It was reported that during a procedure of the mildly calcified, mildly tortuous, 90% stenosis, de novo iliac artery, during the first inflation of the 10x29x135mm omnilink elite stent delivery system (sds), the balloon expanded at the proximal end and the stent implant moved on the balloon, distally, but was not implanted or dislodged.The sds was removed from the patient anatomy without issue.Outside the anatomy the sds balloon was again inflated and it was confirmed that just the proximal end inflated, resulting in stent movement on the balloon and dislodgement.A non-abbott stent was placed at the target lesion and the procedure was completed.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the otw omnilink elite stent implant was the only part returned; therefore, the reported difficulties could not be confirmed.Based on visual analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances or exceptions.A query of the complaint handling database revealed no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.

• 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: 4481253
• MDR Text Key: 5345055
• Report Number: 2024168-2015-00588
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/09/2015

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: 06/30/2017
• Device Catalogue Number: 1012633-29
• Device Lot Number: 4010941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2015
• Initial Date FDA Received: 02/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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