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

Catalog Number 1012624-29

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/29/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure of the non-tortuous, non-calcified external iliac artery the omnilink elite stent was deployed; however, the balloon would not deflate.The device was manipulated several times and negative was drawn twice when the balloon was partially deflated and the sheath advanced over the balloon.It was removed without further issue.It was noted that the balloon manipulation was about 5 minutes before removal; however, the patient remained stable and there was no clinically significant delay nor adverse patient effect.The procedure was completed after angiography confirmed a good result.No additional information was provided.

Manufacturer Narrative

(b)(4).The stent remains in the vessel; the stent delivery system was received.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the returned device analysis confirmed the difficulty to deflate.A search of the complaint handling database was performed and no other incidents were identified from this lot for deflation difficulties.A search of the lot history record for this specific lot indicated no related non-conformance records; however, an expanded investigation revealed the difficulty in deflation may be due to manufacturing.The related record and complaint review do not indicate evidence of a wider systemic issue with the manufacturing process of the omnilink lot in question or that the deflation issue observed affects a larger product population.These devices will continue to be monitored.

• 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: 4271200
• MDR Text Key: 5230932
• Report Number: 2024168-2014-07713
• 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,Followup
• Report Date: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 1012624-29
• Device Lot Number: 4082141
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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
• Patient Age: 78 YR