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

Catalog Number S-55-150-120-P6

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

Patient Problems Pain (1994); Thrombosis (2100)

Event Date 07/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.The lot history record for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of thrombosis and pain are listed in the supera instructions for use as known potential patient effect.Based on the case information, 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 issue with respect to manufacture, design or labeling.The additional supera devices referenced are being filed under separate medwatch reports.

Event Description

It was reported that in-stent thrombosis was observed via angiography in the supera stents that were deployed on (b)(6) 2016.The stents were located in the superficial femoral artery and the popliteal.The procedure was successful and without issue.There was no record of existing thrombosis in the patient prior to stenting.The patient was experiencing pain at rest which led to the angiography which took place on (b)(6) 2016 revealing in-stent thrombosis.Thrombolysis was performed and on the following day a non-abbott stent was placed.The patient returned again approximately 1 month later with repeat in-stent thrombosis for which the patient was sent for surgery for an above the knee amputation.It was confirmed that the patient had not been compliant with his post-procedural medication.No additional information was provided.

• 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: 7139876
• MDR Text Key: 95548568
• Report Number: 2024168-2017-10066
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08975370026337
• UDI-Public: 08975370026337
• 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
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: S-55-150-120-P6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2017
• 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
• Treatment: STENT: SUPERA (X2)
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 49 YR
• Patient Weight: 100