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

Catalog Number SE-06-020-120-6F

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Difficult to Remove (1528); Inaccurate Delivery (2339)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: guide wire: 0.018 glidewire advantage, sheath: 6f terumo.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 the procedure was to treat a de novo lesion located in the heavily calcified, heavily tortuous, 95% stenosed, mid superficial femoral artery.After pre-dilatation was performed with a 6 x 20 mm balloon, deployment of the 6 x 20 mm supera stent was started.Only 1 cm of the stent deployed when the thumb advancer stopped moving forward.The deployment lock was unlocked and another attempt was made to deploy the stent by fully advancing the thumb advancer which failed.The decision was made to release the last 1 cm of the stent by pulling the catheter back which also failed.The thumb advancer was pulled back and both the system and deployment locks were closed.An attempt was then made to withdraw the whole stent back into the 6f sheath; however, during retraction, at the level of the right common iliac, resistance was felt and the delivery system became stuck at the entrance of the sheath and could not be removed.Suddenly the stent jumped out of the catheter and at that same time the tip of the delivery system was noted to have separated.It was observed on fluoroscopy that the separated tip was located below the iliac bifurcation between the vessel wall and the stent.An attempt was made to snare the supera stent implant; however, during this attempt, the separated tip moved to the left side.Finally, the decision was made to compress the supera stent implant against the vessel wall with a covered stent.An omnilink elite stent was used to compress the separated tip to the vessel, the blood flow was good; therefore, the intervention was stopped.The final outcome of the patient is good.The initial stenosis was treated with a short balloon expandable stent.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspection was performed on the returned device.The reported deployment issue, difficulty removing and inaccurate delivery was unable to be confirmed as the stent had already been fully 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 issue.The difficulty removing, tip detachment, inaccurate delivery, additional treatment and device embedded in vessel are 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: 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: 6640535
• MDR Text Key: 77554214
• Report Number: 2024168-2017-05049
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• 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-06-020-120-6F
• Device Lot Number: 6071361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• 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