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

Catalog Number 11012-59

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 mildly tortuous lesion in the femoral vein.A 9.0x59 mm omnilink balloon expandable stent (bes) system was difficult to position through a 6f sheath.Resistance was felt during removal of the bes against the sheath.The distal end struts of the stent were noted to be flared.A new 8.0x59 mm omnilink stent was implanted to successfully complete the procedure.There was no adverse patient effect or a reported clinically significant delay in the procedure.No additional information was provided.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was received: the procedure was to treat a lesion in the common iliac artery.There was no additional information provided.

Manufacturer Narrative

(b)(4).Correction: event description, (b)(4).Evaluation summary: visual, dimensional and functional inspections were performed.The reported material deformation was confirmed.The reported difficulty to position and remove were unable to be performed due to the noted stent damage.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 lot revealed no other similar incidents reported for the lot.The investigation determined the difficulty to position, difficulty to remove and stent damage appear to be related to circumstances of the procedure.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
• MDR Report Key: 7543402
• MDR Text Key: 109381163
• Report Number: 2024168-2018-03923
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/12/2018

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: 10/31/2020
• Device Catalogue Number: 11012-59
• Device Lot Number: 7051641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/05/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH: 6F