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

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

Patient Problems Embolism (1829); Stenosis (2263); Pseudoaneurysm (2605)

Event Date 05/01/2012

Event Type  Injury  

Event Description

This was reported through a research article identifying the supera, which may be related to embolism, stenosis, pseudoaneurysm, and required medical intervention.Specific patient information is documented as unknown.Details are listed in the attached article, titled: primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents.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.Date of event estimated as seven months after estimated implant date ((b)(6) 2012).Date of implant estimated as (b)(6) 2011.The reported patient effects of pseudoaneurysm, embolism, and restenosis 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).

• Brand Name: SUPERA PERIPHERAL 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: 3731877
• MDR Text Key: 4328374
• Report Number: 2024168-2014-02152
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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,Followup
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 04/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/21/2014
• 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