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

Catalog Number 11003-59

Device Problems Positioning Failure (1158); Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the mid common iliac artery with mild tortuosity, mild calcification and 90% stenosis.A 7x59mm omnilink elite over the wire (otw) stent system was prepped outside the anatomy prior to use, the elite was inserted through the sheath and advanced toward the target lesion.An attempt was made to inflate the balloon three times but the balloon did not inflate.The stent was not deployed.Upon removal of the device from the patient anatomy, the elite was inspected, flushed and a hole was noted in the balloon between the tip and proximal part of the stent.Another elite stent was used to successfully complete the procedure.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).Visual and functional inspection was performed on the returned device.The reported difficulties were confirmed.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history of the reported lot revealed no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.

• 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: 5498258
• MDR Text Key: 40268724
• Report Number: 2024168-2016-01574
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

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: 08/31/2018
• Device Catalogue Number: 11003-59
• Device Lot Number: 5030241
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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