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

Catalog Number SE-05-150-120-6F

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

Patient Problems Pain (1994); Thrombosis (2100)

Event Date 11/18/2014

Event Type  Injury  

Event Description

It was reported that the procedure on (b)(6) 2014 was to treat a totally occluded mid to distal superficial femoral artery.An armada 35 balloon catheter was used to pre-dilate the lesion first and then multiple inflations with a 6x100 armada 35 were performed across the sections to achieve a working lumen to implant the supera.A residual recoil stenosis was seen after pre-dilatation that was attempted to be resolved with another pre-dilatation (2-3 mins).The supera 5x150x120 stent was implanted slowly and carefully, but successfully in the critical region, deploying the stent before and after this segment.Angiography performed post-implant showed no severe elongation in the critical segment, but a short portion of the occlusion that did not show perfect flow; therefore, post-dilatation was performed in this region and was effective to show a good final result with no residual stenosis.Clopidogrel was prescribed at discharge.One month later on (b)(6) 2014, the patient was rehospitalized for pain was felt after 20 seconds in a squatting position.In-stent thrombosis was observed.After 18 hours of thrombolytic treatment the angiogram showed flow reestablishment within the stented section.The patient is taking acenocumarol to prevent thrombus and is in a good patient state of health.The doctor suspects that a small thrombus formed after pre-dilatation because the stent deployment was good and did not show severe elongation across the critical segment.After the thrombolytic treatment, the flow was fully restored and the critical region did not show any turbulence.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.The reported patient effect thrombosis is a known potential patient effect as listed in the supera instructions for use (ifu).Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.

• 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: 4348221
• MDR Text Key: 5137900
• Report Number: 2024168-2014-08325
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: SE-05-150-120-6F
• Device Lot Number: 02338062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 90