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

Catalog Number 11004-59

Device Problems Inflation Problem (1310); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2015

Event Type  Injury  

Event Description

It was reported that during a procedure to treat a de novo lesion in the iliac artery with heavy calcification and no tortuosity, pre-dilatation was performed with a 5x40 mm non-abbott balloon catheter.A 8.0x59 mm otw omnilink elite stent system was advanced and positioned at the target lesion.The balloon was inflated; however, the balloon would not inflate over 4 atmospheres.Reportedly, the physician felt there was a leak (rupture) at the balloon.The stent system could be removed from the patient anatomy without issue and the partially deployed stent remained at the target lesion on the guide wire.The 5.0x40 mm non-abbott balloon catheter was advanced and then a 8.0x40 mm non-abbott balloon catheter to complete stent deployment.The final result was good.There was no adverse patient effect.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The device has been received.Investigation is not complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported inflation issue and balloon rupture were able to be confirmed.Based on a visual and functional analysis of the returned device, there is no indication of a product deficiency.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.

• 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: 4712217
• MDR Text Key: 5665682
• Report Number: 2024168-2015-02202
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 03/30/2015

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: 05/31/2018
• Device Catalogue Number: 11004-59
• Device Lot Number: 4120841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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 Outcome(s): Required Intervention