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

Catalog Number S-55-080-120-P6

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported that during a procedure to treat a lesion in the right popliteal to the distal superficial femoral artery with moderate calcification, pre-dilatation was performed with a 6x80 mm balloon catheter for 3 minutes.Reportedly, there was diffuse disease among the 80 mm segment of the lesion.Atherectomy was performed.The 5.5x80 mm supera self-expanding stent system (sess) was then advanced without resistance and deployment was initiated with the thumbslide; however, toward the end of deployment the proximal portion of the stent was not being pushed out of the outer sheath when the thumbslide was advanced distally and then proximally.Several attempts were made to advance the thumbslide distally and proximally; however, the ratchet was not deploying the stent.An attempt was made to re-flush the system in case there was any stickiness between the supera stent system and the surepath guide wire; however, the stent was still not able to be deployed.Reportedly, there were no issues noted with the surepath guide wire.An attempt was made to unlock the deployment lock to deploy the stent and the stent was still not able to be deployed.At this point, the stent was too far deployed to pull everything out of the patient anatomy, so the decision was made to deploy the stent with a pin and pull method.The 6f sheath was pushed in while the stent system was pulled out and the stent was able to be deployed; however, the proximal portion of the stent became elongated by 4 cm.The stent system was simply withdrawn from the patient anatomy without any issue.Post dilatation was performed using the 6.0x80 mm balloon catheter.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned and the reported deployment difficulty could not be confirmed as the stent had already been deployed.Based on visual analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances related to the reported event.A query of the electronic complaint handling database indicated there had been no similar incidents reported for this lot.Based on the reviewed information, no product deficiency was identified.

• 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 462
• Manufacturer (Section G): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4348488
• MDR Text Key: 5173619
• Report Number: 2024168-2014-08344
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: S-55-080-120-P6
• Device Lot Number: 02255059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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
• Treatment: GUIDE WIRE: SUREPATH
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 84