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

Catalog Number S-45-040-120-P6

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.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.

Event Description

It was reported that the patient underwent a procedure to treat a lesion in the proximal popliteal artery.Pre-dilatation was performed using a 4.0 x 100 mm dilatation catheter.The supera stent delivery system was advanced to the target lesion and the stent was deployed; however, the stent jumped forward, so that it was partially deployed in the target lesion.There was no difficulty noted during deployment of the stent.A second supera stent was then deployed at the proximal portion of the lesion.There was no clinically significant delay and no adverse patient sequelae.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): WEBSTER, TX USA REG#3005325609; abbott vascular; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5618665
• MDR Text Key: 44121496
• Report Number: 2024168-2016-02728
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/28/2016

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 Expiration Date: 09/30/2016
• Device Catalogue Number: S-45-040-120-P6
• Device Lot Number: 02394051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• 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