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

Device Problems Improper or Incorrect Procedure or Method (2017); Material Deformation (2976)

Patient Problems Embolism (1829); Hemorrhage/Bleeding (1888); Ischemia (1942); Occlusion (1984); Thrombosis (2100); Stenosis (2263); Claudication (2550); Pseudoaneurysm (2605)

Event Date 10/11/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The mean age provided was 75.3 years majority of patients were male (68 of 97 patients were male).Date of event and implant date: estimated dates.The unique device identifier (udi) is unknown because the part number and lot number were not provided.(b)(4).The devices were not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar incident query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.It should be noted that the reported patient effects of embolism, hemorrhage, ischemia, occlusion, thrombosis, restenosis, claudication, pseudoaneurysm and surgery are known potential patient effects as listed in the supera instructions for use (ifu).A conclusive for the reported difficulties and subsequent patient effects could not be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Article: ramon l.Varcoe, et al, a real-world experience with the supera interwoven nitinol stent in femoropopliteal arteries: midterm patency results and failure analysis.Journal of endovascular therapy.2016; vol 23(3) 433-441.

Event Description

This event was captured based on review of the article, "a real-world experience with the supera interwoven nitinol stent in femoropopliteal arteries: midterm patency results and failure analysis." it was reported through a research article , identifying supera stents implanted in de novo superficial femoral artery (sfa) or popliteal artery lesions between june 2012 and october 2014, that the stents may be related to hematoma/bleeding, pseudoaneurysm, deep vein thrombosis, distal embolization with thrombus, amputation, restenosis, occlusion with compromised inflow or outflow, neoplastic thrombophilia, stent intussusception, claudication, critical limb ischemia, and gross oversizing in limbs.Treatments included revascularization, amputations, aspiration thrombectomy, and medications.Specific patient information is not documented.Details are listed in the attached article, titled:a real-world experience with the supera interwoven nitinol stent in femoropopliteal arteries: midterm patency results and failure analysis.

• 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: 6826910
• MDR Text Key: 83868516
• Report Number: 2024168-2017-07033
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2017
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR