MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Catalog Number	PRB35-08-020-080
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was attempting to use a protege everflex self-expanding stent to treat a right mid artery moderately calcified lesion in the common iliac with little tortuosity.The artery diameter was 7 mm.No abnormalities were reported in relation to the patient¿s anatomy.The device was removed from its packaging and inspected with no issues noted.The device was prepped as per the ifu.A 6 fr sheath was used with a 0.035" guidewire and no embolic protection was utilized.The vessel was pre-dilated using a 5mm pre-dilation device.The thumbscrew/lock-pin checked for securement prior to procedure.The physician was not met with resistance during advancement.No excessive force was used.The device did not pass through a previously deployed stent.It was reported that the distal portion of the stent would not deploy and free itself from the delivery catheter.The stent was finally freed from the catheter, the stent was pulled distally below the target lesion.The surgeon "tugged" on the stent catheter to free the stent, pulling the stent out of position in the vessel.The stent was deployed outside of the intended lesion site.A new protege 8x40 stent was used to cover the lesion and overlap the initial 8 x 20 protege everflex stent.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the protégé everflex was returned for analysis.The protégé everflex was returned in a post-deployed state.The stent was no longer loaded within the catheter.The safety locking pin was loose.Dried blood was evident throughout the device.The distal tip was retracted back into the distal end of the outer assembly.The strain relief was removed and observed the blue outer detached from the manifold.Under microscope, adhesive was observed at the clear connector.The adhesive was present around the entire radius of the connector.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7053926
• Report Number: 2183870-2017-00523
• Device Sequence Number: 1290076
• Product Code: FGE
• UDI-Device Identifier: 00821684069455
• UDI-Public: 00821684069455
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: PRB35-08-020-080
• Device Lot Number: A336098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention