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 Intimal Dissection (1333); Aneurysm (1708)

Event Date 01/08/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Udi#: in the absence of a reported part number, the udi cannot be calculated.Implant date - estimated.The device was not returned for evaluation.The reported patient effects of aneurysm and dissection are listed in the supera instructions for use as known potential patient effects associated with the use of the device.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the part and lot numbers were not reported.Based on the case information, 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 issue with respect to manufacture, design or labeling.

Event Description

It was reported via presentation that a non-abbott drug coated balloon (dcb) and three supera 6f stents were used to treat a long occlusion in the superficial femoral artery in 2013.The patient presented with severe claudication in the right calf.Six months post procedure vessel remodeling and an aneurysm were observed.It is unknown if the aneurysm was treated.No additional information was provided.Presentation images were reviewed by abbotts director of medical affairs, where it was noted something going on distal to the edge of the stent.Over time this progresses to the aneurysm positive remodeled segment.In the 2 year doppler that segment now has increased proximally to include the distal stent.This area could be related to either vessel trauma due to the dcb or a dissection from either supera or the dcb.

• 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: 7131408
• MDR Text Key: 95317407
• Report Number: 2024168-2017-09940
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/19/2017

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: 11/29/2017
• Initial Date FDA Received: 12/19/2017
• 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): Other
• Patient Age: 68 YR