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

Catalog Number SE-06-040-120-6F

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2014

Event Type  malfunction  

Event Description

Subsequent information from procedure images was received and reviewed by an abbott specialist.The results suggest that the 6mm balloon selected and balloon used to prepare the vessel only achieved 6.2 mm.The reference vessel diameter (rvd) of 6.8 mm (stent outer diameter (od) is required for a 6 mm stent per the sizing chart in the instructions for use (ifu).Other images show the stent diamond pattern reflective of elongation.The stent lengthened during deployment due to oversizing resulting in the proximal end of the stent ending up inside the sheath.The distal end of stent delivery system (sds), tip, and proximal end of stent was inside the introducer sheath.This accounts for the reported pinching of the sds tip in the stent.It was concluded that as the sds was withdrawn proximally through the sheath with the partially deployed stent, the stent released from the sds when resistive forces due to lack of sheath diameter clearance for the sds, tip and partially deployed stent were overcome and the stent released from the sds when it was in the introducer sheath.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported difficult to deploy, difficult to remove could not be confirmed as they were based on circumstances of the procedure.The inaccurate delivery was confirmed as the stent was returned partially deployed in the introducer sheath.Although not reported a tip detachment was also confirmed.Based on the reported information and returned device analysis, there is no indication of a product deficiency.A review of the job traveler revealed no non-conformances that would have contributed to the reported event.The results of the historical data review revealed no other incidents reported for this lot.It should be noted the supera instruction for use (ifu) states: measure the diameter of the reference target bile duct (proximal and distal to the stricture).Select a stent with a labeled diameter equal to the reference diameter of the target bile duct.Based on the reviewed information, no product deficiency was identified.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that using an unspecified artery access approach during a procedure of the unspecified vessel, the 6 x 40 mm supera vertias stent delivery system (sds) was deployed at the lesion; however, the stent could not be released from the stent holder.The entire system was withdrawn from the patient; the stent implant deployed at the end of the vascular sheath.There was no reported adverse patient effect.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

• 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: 3613328
• MDR Text Key: 4278994
• Report Number: 2024168-2014-00702
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P120020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: SE-06-040-120-6F
• Device Lot Number: 02148065
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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