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

Catalog Number S-65-150-120-P6

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158)

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

Event Date 12/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient and the delivery system was reportedly discarded.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 heavily calcified, tortuous, superficial femoral artery (sfa).There were three stents which had been previously implanted in the sfa.Atherectomy was performed.The lesion was pre-dilated and measured to be 6.5mm.A supera percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion 250mm away from the introducer sheath, and stent deployment seemed to be going well.Suddenly, the stent elongated all the way back to the introducer sheath and the tip of the pta catheter separated.A snare device was not available, so the tip of the pta catheter was embedded into the wall of the vessel, through the space in between the struts, with a balloon.A non-abbott stent delivery system was used to push the deployed supera stent down the vessel to a location that would not impede blood flow to other vessels.This was characterized as the best outcome possible, and there was no adverse patient sequela.Although there was a delay in the procedure, it was not clinically significant.The patient was held for observation overnight as a precaution and discharged two days later on (b)(6) 2015.No additional information was provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.Based on the reported information, there is no indication of a product quality issue with respect to manufacture, design, or labeling.A conclusive cause for the deployment difficulty could not be determined.The stent elongation, tip separation and additional therapy are due to operational context.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents from this lot.Based on the information reviewed, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.(b)(4).

• 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): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5357674
• MDR Text Key: 35552204
• Report Number: 2024168-2016-00131
• 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
• Report Date: 01/29/2016

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: 08/31/2016
• Device Catalogue Number: S-65-150-120-P6
• Device Lot Number: 02392070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2015
• Initial Date FDA Received: 01/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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