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

Catalog Number SE-05-100-120-6F

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

Patient Problem Thrombosis (2100)

Event Date 01/22/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction, and the product was not returned.The reported patient effect of thrombosis is a known potential patient effect as listed in the supera instructions for use.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication the reported patient effects were caused by, or related to the design, manufacture or labeling of the device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.(b)(4).The other supera is being filed under a separate manufacturing report number.

Event Description

It was reported that the initial procedure took place on (b)(6) 2013, during which two supera stents were placed overlapping to treat a chronic total occlusion from the origin of the superficial femoral artery (sfa).Balloon angioplasty was performed on the proximal area with a non-abbott 5 x 40 mm balloon catheter.Angiography confirmed that the supera stents were fully apposed to the vessel wall.There was a good outcome at the end of the procedure with resolution of intermittent claudication.On (b)(6) 2014, a thrombotic occlusion of the sfa was detected and treated with balloon angioplasty using a 5 mm conventional balloon and a 6 x150 mm medicated balloon.On (b)(6) 2014, a thrombotic occlusion was observed again; however, as the patient was stable; therefore, no treatment was performed.There have been subsequent angiographies performed, but the thrombotic occlusion remains unchanged with no further treatment performed.No additional information was provided.

Manufacturer Narrative

(b)(4).Outcomes attributed to adverse patient effects - the box for disability or permanent damage was checked on the initial medwatch report, but should not be checked.

• 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: 5227142
• MDR Text Key: 31317799
• Report Number: 2024168-2015-06895
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: SE-05-100-120-6F
• Device Lot Number: 02163060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 59 YR