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

Catalog Number S-45-100-120-P6

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

Patient Problems Occlusion (1984); Pain (1994)

Event Date 11/13/2014

Event Type  Injury  

Event Description

Subsequent to the initial medwatch, additional information received reported that the patient was critically ischemic.No additional information was provided.

Manufacturer Narrative

(b)(4).There was no reported device malfunction, and the product was not returned.The job traveler for the reported lot revealed no nonconforming reports.The reported patient effects of ischemia, occlusion, pain, and surgery are listed in the supera peripheral stent system, 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.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other supera referenced is being filed under a separate medwatch mfr number.

Event Description

It was reported that the procedure was to treat a superficial femoral artery (sfa) and a popliteal artery performed on (b)(6) 2014.The sfa was treated with a 5.5 x 60 mm supera stent and the popliteal was treated with a 4.5 x 100 mm supera stent.There were no issues during the procedure.On (b)(6) 2014, the patient presented with pain in the leg and no blood flow and on (b)(6) 2014 femoropopliteal bypass surgery was performed.Angiography was not performed to see if there was thrombosis or restenosis in the supera stents.It is unknown at this time why bypass was performed.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 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: 4333721
• MDR Text Key: 5431879
• Report Number: 2024168-2014-08195
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: S-45-100-120-P6
• Device Lot Number: 02217054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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: 61 YR