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

Catalog Number SE-05-100-120-6F

Device Problems Inaccurate Delivery (2339); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the job traveler for this product could not be performed and the historical data for the reported lot could not be reviewed because the product was not returned for evaluation and the lot number was not reported.A conclusive cause for the reported difficulties could not be determined.Based on the information reviewed, there is no indication the issue was caused by, or related to the design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion located in the superficial femoral artery (sfa).During deployment the 5 x 100 mm supera stent implant jumped and after deployment exceeded the lesion length in the distal sfa and extended over a long segment of the healthy proximal sfa.Another supera stent wad deployed in the distal part of the lesion to cover the segment of lesion that was not covered by the first stent.The vessel was patent.The physician was happy with the results and no further treatment was required.No adverse patient effects or clinically significant delay in the procedure were reported.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: 5448042
• MDR Text Key: 38998879
• Report Number: 2024168-2016-01008
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SE-05-100-120-6F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/19/2016
• 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 Age: 87 YR