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 Occlusion (1984); Pain (1994); Perforation (2001); Swelling (2091); Stenosis (2263)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The udi# is unknown because the part number and lot number was not provided.The device was not returned for evaluation.The reported patient effects of occlusion, pain, perforation, stenosis, and surgical procedure are listed in the supera instructions for use as known patient effects.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.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.The additional therapy/non-surgical treatment was related to operational context.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported through a research article identifying supera stents that may be related to limb loss, occlusion, in-stent restenosis, extremity pain and pallor, peroneal artery rupture and limb swelling.Specific patient information is documented as unknown.Details are listed in the attached article titled: analysis of endovascular therapy for femoropopliteal disease with the supera stent.

• 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: 6343207
• MDR Text Key: 67806372
• Report Number: 2024168-2017-01354
• 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: literature
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• 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
• Date Manufacturer Received: 02/14/2017
• 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
• Patient Outcome(s): Required Intervention; Disability