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

Catalog Number	PRB35-05-120-120
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	03/08/2019
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
Physician used a protégé everflex during treatment of a calcified/plaque lesion in the patient¿s superficial femoral artery (sfa).Slight tortuosity and moderate calcification are reported.No damage noted to packaging (i.E.Shelf carton, hoop/tray) embolic protection was not used.The device was prepped without issue.No resistance was encountered during advancement of the device.The device did not pass through a previously deployed stent.No excessive force was used.It is reported the delivery system became stuck and a piece of the proximal stent broke off during attempted removal resulting in the detached portion embolising at the target lesion.Another everlfex entrust was placed over the detached portion.No further patient injury reported for this event.
Additional Manufacturer Narrative
Additional information: resistance in the delivery system was encountered when unsheathing the stent.Approximately 1 cm of the proximal stent deployed.The physician was not able to unsheath the rest of the stent so he made the decision to remove the entire device.During removal of the device the stent became stuck on the proximal up and over 6fr sheath and a piece of the stent detached.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the protégé everflex was inspected and observed the stent was not loaded the deployment system and was loose within the pouch.An inspection of the deployment system showed the deployment grips were pulled together and the inner/guidewire tubing was advance and exposed outside of the catheter shaft outer with the retainer exposed.A bend to the inner assembly was noted at the distal edge of the retainer.It is possible the bend occurring during handling of the deployment system post procedure.The stent was approximately 10cm long.According to the product labeling, the stent should be 12cm.One end of the stent was fractured, no tantalum markers were identified.The opposite end of the stent showed the tantalum markers intact.It is likely the fractured end of the stent was the distal end of the sheath and the proximal end was undamaged.The returned stent was likely deployed outside the patient.The returned portion of the stent showed no damage indicating the struts of the stent interfered with the vessel wall during retrieval.The dist al end of the stent was likely exposed within the vessel and may have caught upon the distal tip of the sheath and/or vessel wall.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: 8420981
• Report Number: 2183870-2019-00132
• Device Sequence Number: 16706627
• Product Code: FGE
• UDI-Device Identifier: 00821684068625
• UDI-Public: 00821684068625
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2019

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: 10/11/2020
• Device Catalogue Number: PRB35-05-120-120
• Device Lot Number: A538063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 06/06/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 03/26/2019; 06/17/2019
• 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