MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLX; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number PRP35-08040120V01

Device Problems Premature Activation (1484); Failure to Advance (2524)

Patient Problem Injury (2348)

Event Date 12/15/2014

Event Type  Injury  

Event Description

The procedure was transverse sinus vein stenting, performed in (b)(6).The protege everflex stent did not cross, and started to deploy when advancing.The stent was removed because it began to deploy before reaching the target area.Patient injury reported.Current condition is stable.The patient was brought back the next day and a jugular vein puncture was performed and another self expanding stent was used through a 7f sheath.

Manufacturer Narrative

A review of the manufacture records for this device did not reveal any discrepancies relevant to the reported event.

Manufacturer Narrative

This supplemental mdr is being submitted as a part of a retrospective review / remediation effort performed at the covidien (b)(4) location, following medtronic¿s acquisition of covidien.A capa has been opened to manage the actions related to remediation of complaint files and any required mdr reporting.

Event Description

Evaluation summary: the protege everflex stent delivery system (sds) was received for evaluation with the distal 1/2 cell (1 strut level) deployed.No ancillary devices or cine images from the procedure were available for this investigation.The lock-mechanism was snug-tight.The strut level was significantly deformed as was the distal edge of the sds outer sheath.The cause of the deformation could not be determined.The device was flushed and loaded into the deployment force fixture.The stent deployed with 0.62 lbs.Of force (design specification: { 3.0 lbs.).The distal deployment paddle was removed from the manifold assembly and the inner shaft was pulled back to expose the hypotube section normally secured by the lock thumb-screw.The hypotube component exhibited two witness marks indicating that it had been locked by the manifold thumbscrew.The distal tip was drawn up to the outer sheath distal tip.The tip was introduced into a 6fr gage.The tip would pass through the gage but the (deformed) distal edge of the outer sheath would catch on the gage edge.The maximum width over the sheaths distal edge was 0.0805 and the maximum width proximal to the noted deformation was 0.0785.Note: it should be noted that the protege everflex is not approved for use in the jugular vein.

• Brand Name: PROTEGE EVERFLX
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie riley ; 4600 nathan lane n; plymouth, MN 55442 ; 7633987000
• MDR Report Key: 4423719
• MDR Text Key: 5279798
• Report Number: 2183870-2015-00012
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: PRP35-08040120V01
• Device Catalogue Number: PRP35-08040120V01
• Device Lot Number: 9829457 EXP. DT.14.11.2015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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): Other
• Patient Age: 10 YR