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

Catalog Number	PRB35-06-150-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a protégé everflex with a spider embolic protection device to treat a calcified cto in the distal superficial femoral artery.There device was prepped with no issues identified.There was no damage to the packaging.Pre-dilation was performed with a evercross device.No resistance was encountered when advancing the device and it did not pass through a previously deployed stent.It was reported that the stent deployed as expected but when the physician went back in with another stent it was noticed that the distal portion of the first stent had broken off and was floating in the popliteal.A snare was used to remove the segment of the broken stent.No injury was reported.
Additional Manufacturer Narrative
Additional information: physician confirmed that no portion of the stent broke off; a portion of the delivery catheter broke off.The snare retrieved the broken portion of the catheter.The physician is satisfied with the stent in the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: the protégé everflex was returned for evaluation.The device was inspected and the deployment system was in a post-deployment state.The deployment grips were pulled together with the safety lock loose.The distal tip and clear inner of the catheter with the retainer was fractured off from the rest of the deployment system.The tip and the inner assembly of the catheter was inspected.The retainer was present on the inner tubing.The inner tubing was fractured approximately 17.5cm from the distal tip, between the proximal end of the retainer bonding and the nylon spline segment.The fracture was radial, and the fracture face was ductile.Narrowing of the tubing was observed at the proximal end which may indicate stretching.The evidence indicates the catheter was attempted to be removed under resistance which led to a fracture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8085087
• Report Number: 2183870-2018-00514
• Device Sequence Number: 16557459
• Product Code: FGE
• UDI-Device Identifier: 00821684059982
• UDI-Public: 00821684059982
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K060057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2019

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: 10/01/2021
• Device Catalogue Number: PRB35-06-150-120
• Device Lot Number: A716915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/19/2018; 01/18/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/07/2018; 01/31/2019
• 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