MAUDE Adverse Event Report: AV-TEMECULA-CT SUPERA SELF-EXPANDING STENT SYSTEM; SELF EXPANDING STENT SYSTEM

Catalog Number SE-05-060-120-6F

Device Problems Difficult or Delayed Positioning (1157); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that following pre-dilatation, three supera stents were implanted in the distal superficial femoral artery (sfa) to the mid/proximal popliteal, heavily calcified lesion with excellent results.Moderate stenosis was noted in the mid-proximal sfa, close to the bifurcation.A 5x60mm supera stent was positioned at the lesion, overlapping approximately 1 centimeter of a previously implanted supera stent.During deployment and while advancing the thumbslide, there was no further stent deployment observed.The thumbslide was advanced and retracted multiple times with no success.The operator attempted to unlock the deployment lock and fully advance the thumbslide with still no success.The device was locked again and the operator attempted to carefully retract the system, however, the stent was stuck in the delivery system.The physician tried to invaginate the stent and retract the system.After four times, the stent became loose (unstuck) and was placed at the lesion site fully apposed to the vessel wall with desirable results.There were no adverse patient effects and there was no clinically significant delay.There was no additional information provided regarding this device issue.

Manufacturer Narrative

(b)(4).Evaluation summary: visual inspection was performed on the returned device.The deployment difficulty was not able to be confirmed as the stent had already been deployed.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 incidents.The investigation was unable to determine a cause for the reported deployment difficulty.Based on the information reviewed, 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 initial report, additional information was obtained: two supera stents (not three as initially reported) had been implanted without reported issue, prior to the complaint device.

• Brand Name: SUPERA 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: 7037999
• MDR Text Key: 92290744
• Report Number: 2024168-2017-09037
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P120020
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: SE-05-060-120-6F
• Device Lot Number: 6071561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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
• Patient Outcome(s): Required Intervention