MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	PRB35-06-150-120
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the protégé everflex stent delivery system was returned for evaluation.It was observed that the stent was partially exposed upon receiving.No ancillary devices, cines images or procedural notes were received for evaluation.The protégé everflex stent delivery system was examined.It was observed that the safety lock was tight upon examination.The stent was partially pre-deployed on the device.Approximately 1.80cm of the device was exposed from the distal tip.Approximately 0.30cm of the stent was exposed.The radiopaque markers appear to all be intact.An unknown substance was observed on the exposted portion of the stent.The inner distal assembly was cut just proximal to the retainer bond to allow examination of the stainless steel hypotube.Witness marks were noted on the stainless steel hypotube - these are as a result of the safety locking pin engaging the stainless steel hypotube.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a protege everflex stent to treat an unknown lesion.The device was prepped as per the ifu with no issues identified.The thumbscrew/lock-pin was checked for securement prior to procedure.The procedure used a non-medtronic 6 fr sheath and a 0.035" non-medtronic guidewire.There was no damage to the deployment mechanisms or device handle prior to deployment issue.There was no resistance advancing the device.The device did not pass through a previously deployed stent and no excessive force was used.No embolic protection was used.The stent started to deploy before it was removed and a new stent was used without incident.The physician stated they noticed a few mms of the distal stent markers exiting the stent delivery catheter under floroscopy as it exited the sheath to be placed at the lesion.The stent was then removed undeployed via the sheath still attached to the delivery system and a new stent was placed without incident.No patient injury was reported.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7380737
• Report Number: 2183870-2018-00194
• Device Sequence Number: 13757052
• Product Code: NIP
• UDI-Device Identifier: 00821684069264
• UDI-Public: 00821684069264
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/29/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/17/2020
• Device Catalogue Number: PRB35-06-150-120
• Device Lot Number: A525699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1