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

Catalog Number 1012631-39

Device Problems Peeled/Delaminated (1454); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2017

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 relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the iliac artery.An 8 x 39 mm otw omni elite stent system was being advanced into a 6f sheath; however, resistance with the sheath was felt.The device was remove and the balloon had shredding (peeling).The device was not used.The procedure was successfully completed with a new 8 x 39 mm otw omni elite stent system.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspection was performed on the returned device.The reported resistance was not confirmed using a proxy sheath.It may be possible that the inner diameter of the 6f introducer sheath was smaller than the labeled recommended minimum id and may have contributed to the reported resistance; however, without having the introducer sheath to examine, this could not be confirmed.Foreign material was found on the device and sent for chemical analysis.The foreign material was likely scrapped from the inner surface of the introducer sheath.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 6491290
• MDR Text Key: 72942039
• Report Number: 2024168-2017-03163
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 1012631-39
• Device Lot Number: 5120741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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
• Treatment: SHEATH: 6F
• Patient Age: 81 YR
• Patient Weight: 78