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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Stenosis (2263)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The 5.0 x 60 mm supera is being filed under a separate medwatch mfr number.

Event Description

It was reported the procedure was to treat an in-stent restenosis of a supera in the mid-distal superficial femoral artery (sfa).Balloon angioplasty was performed on the restenosis, at which time a dissection occurred under the supera stent.The decision was made to place another supera stent in the distal part of the sfa, overlapping the previously implanted supera stent.The 5 x 60 supera was advanced, but met resistance and the stent was pushed forward out of the catheter due to the pushing, the stent released before the release button was used.The stent was 1 1/2 cm still in the shaft and folded back for 1 cm.An extra balloon was used to dilate the section that was folded back of the stent.The patient is now under close monitoring in case of issues occurring in that area.Although it was reported there was a delay due to the additional percutaneous transluminal angioplasty (pta), the delay was not clinically significant as there was no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).The incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the stent remains in the anatomy.The reported patient effects of intimal dissection and restenosis are listed in the supera instructions for use, as known patient effects.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information reviewed, there is no indication of a product quality issue.Based on the case information a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.

• 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: 5790968
• MDR Text Key: 49436441
• Report Number: 2024168-2016-04530
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 09/15/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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