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

Catalog Number 11006-39

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Medical devices: dil cath: cook 180 j wire, guide cath: 6fr 45cm terumo.The device was not returned for analysis.It may be possible that the non-abbott 6fr sheath used during the procedure was not the appropriate id; however, the omnilink elite and sheath was not returned for analysis, therefore, the exact inner diameter is unknown.The investigation was unable to determine a conclusive cause for the reported difficulties.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported revealed no other incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a non-tortuous and non-calcified lesion in the right to left iliac artery.Difficulty advancing a 10x39mm otw omni elite balloon expandable stent system through a 6fr sheath was felt and the stent system would not track over the non-abbott guide wire.A new guide wire was advanced to provide more stiffness.The stent was deployed; however, the stent system became stuck and there were issues removing the system though the sheath.Lots of force had to be used to remove the stent system.The procedure was successfully completed with an omni-link elite stent.The patient experienced discomfort at the puncture site due to the extra pushing and pulling needed with the stent delivery system.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filed report, additional information was received stating: the guide wire did not seem to be the issue since the stent system also did not track easily over the stiffer guide wire.The issue appears to be the compatibility of the stent system with the non-abbott 6f sheath.No additional information was 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 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: 7515428
• MDR Text Key: 108490413
• Report Number: 2024168-2018-03594
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 06/01/2018

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: 07/31/2021
• Device Catalogue Number: 11006-39
• Device Lot Number: 8021241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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