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

Catalog Number SE-05-180-080-6F

Device Problems Detachment Of Device Component (1104); Positioning Failure (1158); Difficult to Remove (1528); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported the procedure was to treat a long chronic totally occluded lesion in the mid to proximal superficial femoral artery (sfa).The supera was unpacked and prepped per instructions for use (ifu).Pre-dilatation was performed with a 6.0 x 100 mm balloon catheter.The balloon was inflated twice to 12 atmospheres for 2 minutes each time.The supera was advanced and initial deployment was appropriate; however, during deployment, the stent massively elongated into the introducer sheath.The physician could not control the delivery system during deployment to pack or compress the supera stent appropriately.The thumb slide was fully retracted to the start position and both the system and deployment levers locked prior to removal and during this step the tip separated within sheath and delivery system was stuck.The delivery system was removed with the stent 95% deployed, the separated tip in the sheath along with the guide wire as a single unit.Some resistance was observed during removal.Then, a 7f sheath was inserted to patients anatomy and another supera stent and a non-abbott stent were placed successfully to treat the lesion.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: (b)(4).The device was returned for evaluation and the reported deployment issue, elongation and difficulty removing was not able to be confirmed as the stent had already been deployed.The tip detachment was confirmed.Based on visual and functional analysis of the returned device, there is no indication of an issue/observation caused by, or related to the design, manufacture, or labeling of the device.A conclusive cause for the reported deployment difficulty and stent elongation could not be determined.The difficulty during removal and additional damage to the device is due to operational context.A review of the lot history record revealed no non-conformances.A query of the electronic complaint handling database revealed no other incidents reported from this lot.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.

• 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: 5321265
• MDR Text Key: 34883285
• Report Number: 2024168-2015-07936
• 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,Followup
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: SE-05-180-080-6F
• Device Lot Number: 5031761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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