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

Catalog Number SE-04-100-120-6F

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  Injury  

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 relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the common femoral artery with heavy tortuosity and heavy calcification.The vessel diameter was 4-4.5mm.Atherectomy was not performed.The vessel was prepared by inflating a 5mm balloon up to 12 atmospheres for 30 seconds.A 6 french introducer sheath was inserted into the anatomy.A 4x100mm supera self-expanding stent system (sess) was advanced toward the target lesion.An attempt was made to deploy the stent and the stent partially deployed.The stent driver was re-pushed to see if this operation can make it work but the stent did not completely expand.The stent system was removed and resistance was noted with the introducer sheath.Using fluoroscopy it was noted that the stent position moved upward and the supera catheter tip separated and was found in the stent.The combined stent/catheter tip was removed from the patient anatomy via snare device.Ultimately the lesion was treated using a 4x80mm supera stent.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual and dimensional inspections were performed on the returned device.The deployment difficulty and migration were unable to be confirmed as the stent had already been deployed.The tip detachment was confirmed.The resistance noted during removal was not confirmed as it was based on case circumstances.The investigation was unable to determine a conclusive cause for the reported deployment issue.The tip detachment, stent migration, resistance during removal and additional treatment are due to operational context.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.A cine of the procedure was received and reviewed by a clinical specialist who concluded the following: while it was reported that the treatment area was the common femoral (cf) artery based on the image provided for review the stent appears to have been deployed in the proximal superficial femoral artery.The report indicates that after partially deploying the stent the physician had difficulty in operating the deployment mechanism.At this point, with the stent partially deployed, the stent delivery system was removed when, during this process, the physician felt resistance noted with the introducer sheath.It was reported that the deployment lock was unlocked and the thumb slide advanced to the most distal position on the handle.During the deployment the delivery system process appears to have stopped or failed to further deploy the stent.Per the ifu, and noted in multiple locations, if at any time during stent system advancement or stent deployment the entire system should be removed together with the introducer sheath or guiding catheter as a single unit.Based on the report details the physician may have failed to remove the entire system with the introducer sheath as a single unit, likely leading to the tip detachment when force was applied to the delivery system.While it is unclear as to when the deployment lock was placed in the open position, per the ifu this is to only occur once the entire stent has been confirmed to have been deployed under fluoroscopy.Without confirmation that both the system lock and deployment lock were in the locked position prior to the device removal attempt the potential for tip detachment is extremely high.In conclusion, the user's failure to follow the ifu may have been the primary influence in the tip detachment occurring.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.

• 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: 5894992
• MDR Text Key: 52721984
• Report Number: 2024168-2016-05592
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P120020
• 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: 09/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: SE-04-100-120-6F
• Device Lot Number: 6021061
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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