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

Catalog Number SE-06-200-120-6F

Device Problems Positioning Failure (1158); Kinked (1339); Premature Activation (1484); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The stent implant was returned partially deployed; thus, the reported failure to deploy was not confirmed although the reported resistance and kink were confirmed.The investigation determined the reported difficulties to be related to the patient anatomical conditions.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during a procedure of the heavily tortuous, heavily calcified, mid superficial femoral artery (sfa) using a contralateral approach the lesion was pre-dilated with a 7 mm unspecified balloon.The patient had heavily kinked iliac arteries and the supera stent system met anatomical resistance at the aortic bifurcation but was positioned at the lesion.During deployment the stent failed to deploy.The device was removed and a non-abbott stent was used in the procedure.Outside the anatomy a kink was noted to the delivery system.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed the stent was partially deployed.

• 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: 6190636
• MDR Text Key: 63198557
• Report Number: 2024168-2016-09047
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08975370022476
• UDI-Public: (01)08975370022476(17)170831(10)5091861
• 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: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SE-06-200-120-6F
• Device Lot Number: 5091861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Treatment: GUIDE WIRE: GLIDEWIRE ADVANTAGE 0.018