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

Catalog Number S-50-120-120-P6

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.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 severely calcified lesion in the mildly tortuous, 5 mm diameter proximal popliteal artery.An introducer sheath was positioned in the common femoral artery and pre-dilatation was performed via inflation of a 4.0 mm x 100 mm armada 35 balloon to 12 atmospheres.A 5.0 mm x 120 mm x 120 cm 6f supera peripheral self-expanding stent system (sess) was advanced to the lesion without resistance and was deployed without difficulty; the stent was confirmed under strict fluoroscopy to have completely exited the sheath and was confirmed to be deployed from the device prior to initiating withdrawal.The supera delivery system was then withdrawn without resistance under fluoroscopy, however, the nose cone tip detached in the patient during withdrawal.A 4.0 x 33 mm xience alpine stent was deployed embedding and securing the nose code against the vessel wall.There were no adverse patient sequelae.Additional information has been requested.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.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 identified no other similar incidents reported from this lot.The reported patient effect of device embedded in vessel or plaque is listed as known patient effect of peripheral stenting procedures.It should be noted that the supera peripheral self-expanding stent systems instruction for use (ifu) states: prepare the vessel utilizing standard angioplasty technique using a balloon size greater than or equal to the stent diameter.Refer to the balloon instructions for use.The recommended balloon size should be equal to or greater than 5.0 for a 5.0mm stent implant.It is unknown if the deviation to the ifu contributed to the reported separation.Since the device was not returned for evaluation there is insufficient evidence to determine if a product quality issue, with respect to the design, manufacture, or labeling of the device, contributed to the reported separation of the nose cone tip of the supera device.(b)(4).

Event Description

Subsequent to the initial filed medwatch report the following additional relevant information was received: the procedure was to treat a severely calcified lesion in the mildly tortuous, 5mm diameter left superficial femoral artery.The location of the detached nose cone that was secured by the alpine stent is in the left proximal popliteal artery.An angiogram confirmed adequate flow.No additional information was provided.User facility medwatch report received that states: surgeon performing a percutaneous transluminal coronary angioplasty (ptca) and stenting of the left superficial femoral artery.Upon completion of the stent deployment when the delivery device was removed over the wire, the nose cone of the device was dislodged and remained in the proximal left popliteal artery against the wall of the artery, wires exchanges were performed in the area where the nose cone was located - the area where the nose cone was located was stented with an expandable stent deployed across the area of the nose cone, securing it in place.Angiogram follow up with adequate flow.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filed medwatch report, the following additional information was received from the physician during a meeting on 30 may 2017: prior to deploying the 5.0mm x 120mm x 120cm 6f supera peripheral self-expanding stent in the popliteal artery, the lesion had been pre-dilated with the 4.0mm-sized armada 35 balloon because the patient reference vessel diameter was 4.0mm, not 5mm as previously reported.Additionally, the reported detached nose cone tip was located within the distal 3rd portion of the implanted supera stent and then secured using the 4.0 x 33mm xience alpine as previously reported.No additional information was provided.

• 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: 6376677
• MDR Text Key: 69031141
• Report Number: 2024168-2017-01765
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: S-50-120-120-P6
• Device Lot Number: 6111061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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
• Patient Age: 88 YR