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

Catalog Number S-55-040-120-P6

Device Problem Material Deformation (2976)

Patient Problem Vasoconstriction (2126)

Event Date 10/23/2014

Event Type  Injury  

Event Description

It was reported that the supera stent stacked a little bit during deployment in the mildly tortuous, moderately calcified and ulcerated target lesion in the right proximal popliteal artery, leaving approximately 8 mm of the proximal lesion unstented.Reportedly, there were sections in the lesion where the ulceration caused the stent to stack or shorten.The vessel diameter was 5.0 and the vessel had been predilated with a 6.0 balloon dilatation catheter at 10 atmospheres for 90 seconds.The diameter of the balloon reached 6.3, which over-prepared the target lesion.A second supera stent was implanted to cover the first 8 mm of the lesion.This was the physician's first use of a supera stent in the peripheral vasculature.No additional information was provided.

Manufacturer Narrative

(b)(4).A review of the device history record did not reveal any nonconforming material records from this lot.A query of the electronic complaint handling database revealed no other similar incidents reported from this lot.

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.It was reported that the stent remains in the anatomy and the stent delivery system was discarded and is not returning for evaluation; therefore, a failure analysis of the complaint device cannot be completed.Reviews of the lot history record and complaint history could not be conducted because the lot number was not provided.Based on the information reviewed, there is no indication of a product deficiency.

• 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: 4240829
• MDR Text Key: 5072908
• Report Number: 2024168-2014-07304
• 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: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: S-55-040-120-P6
• Device Lot Number: 02246057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 95