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

Catalog Number 1012014-150

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2017

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 additional relevant information.

Event Description

It was reported that the procedure was to treat a non-tortuous, moderately calcified de novo lesion in the proximal right superficial femoral artery which required advancement through an acute abdominal aortic bifurcation.A non-abbott stent was unable to cross the lesion.Then a 5.0 x 150mm absolute pro self-expanding stent was used and successfully crossed the lesion.However, during deployment when the first half of the stent was successfully deployed, the wheel became stiff, a crack was heard and the deployment handle broke in half.The remainder of the stent could not be deployed.The physician simply withdrew the device from the patient, managing to pull out the half-deployed stent and delivery sheath which contained the remaining non-deployed stent.No further attempts to stent the lesion were made.Although there was a delay, it was not clinically significant because there were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The deployment difficulty was unable to be confirmed due to the condition of the returned device.The damage was confirmed.The reported difficulties likely occurred due to case circumstances.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.The investigation determined the reported difficulties were due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initially filed mdr report, it was noted that a distal tip separation had occurred.

• 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: 7100329
• MDR Text Key: 94876040
• Report Number: 2024168-2017-09525
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P110028
• 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: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1012014-150
• Device Lot Number: 5071661
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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
• Patient Age: 69 YR