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

Catalog Number 1012626-39

Device Problem Device Damaged by Another Device (2915)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 06/18/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 that would have contributed to the reported event.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.Based on the reviewed information, no product deficiency was identified.

Event Description

It was reported that the omnilink elite stent was implanted on (b)(6) 2013 in the right common iliac artery.On (b)(6) 2014, the patient had a peripheral angiogram which showed restenosis in the omnilink elite stent.The patient had right flank discomfort which is what brought the patient back to the catheterization lab.The restenosis was dilated with a non-abbott balloon dilatation catheter (bdc) but the omnilink elite stent became distorted.It is believed that the guide wire went through the stent strut and the bdc followed the same path.When the bdc was inflated, the stent became damaged.The stent is now patent.The right flank discomfort resolved.There was no difficulty removing the bdc from the stent.No additional treatment was provided for the stent damage.There were no adverse patient effects related to this device issue.There was no additional information provided.

• 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: 3907025
• MDR Text Key: 22209441
• Report Number: 2024168-2014-04263
• 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: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Catalogue Number: 1012626-39
• Device Lot Number: 2120541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Treatment: DILATATION CATHETER: COYOTE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR