MAUDE Adverse Event Report: AV-TEMECULA-CT ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number 1013016-150

Device Problems Component Missing (2306); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(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 the procedure was to treat a lesion with mild tortuosity and mild calcification in the distal femoral artery.The 6.0 x 150 mm absolute pro ll was advanced and before reaching the target lesion there was great resistance noted, so the complete device was withdrawn without resistance from the patient anatomy.Outside the patient anatomy, the device was released and there was no stent implant noted.It was confirmed the handle remained locked and the stent did not prematurely deploy in the patient.Additionally, fluoroscopy confirmed that the stent was not in the patient's anatomy.Another device was used to complete the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was reported.Return device analysis revealed that the sheath was separated distal to the proximal end of the sheath and the tip was separated at the distal end of the stent holder.Follow-up was performed with the site; however, they stated they were unaware of the device damage.No additional information was provided.

Manufacturer Narrative

Evaluation summary: visual and functional inspection was performed on the returned device.The missing stent was not confirmed; however, the distal sheath was separated including the stent.The failure to advance was unable to be confirmed as it was based on case circumstances.The investigation was unable to determine a cause for the noted separation.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 incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ABSOLUTE PRO LL SELF-EXPANDING STENT SYSTEM
• Type of Device: SELF EXPANDING STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6341024
• MDR Text Key: 67994331
• Report Number: 2024168-2017-01329
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

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: 02/28/2019
• Device Catalogue Number: 1013016-150
• Device Lot Number: 6031761
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2016
• Initial Date FDA Received: 02/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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