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	Fracture (1260)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/12/2019
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
It was reported that the physician was using a protege everflex stent to treat a calcified lesion in the superficial femoral artery(sfa).The device was removed from the packaging with no damage noted.The device was not passed through a previously deployed stent.No resistance was encountered when advancing the device and no excessive force was used.Upon removal, it was reported that the proximal end of the stent broke and came out of the sheath.The remainder of the stent deployed as expected in the intended location.No embolization was reported.The physician was concerned about further fracture of the stent and the damage to the struts so a non-medtronic device was deployed.No harm to the patient was reported.
Additional Manufacturer Narrative
Device evaluation: the protégé everflex deployment system was returned in a post deployment state.The deployment grips were pulled together, and the inner was exposed outside from the distal outer with the retainer being visible.No damages to the deployment system were observed.It was discovered the stent was placed over the strain relief.The one end of the stent as it was loaded over the strain relief showed the tantalum spheres intact.The other end showed a radial fracture to the stent struts approximately 1.5 cm from one end of the stent.The stent struts were elongated out towards the fracture face.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: 8292129
• Report Number: 2183870-2019-00046
• Device Sequence Number: 1620036
• Product Code: FGE
• UDI-Device Identifier: 00821684068625
• UDI-Public: 00821684068625
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 08/10/2021
• Device Catalogue Number: PRB35-05-120-120
• Device Lot Number: A690812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/21/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 05/01/2019
• 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
• Patient Age: 77 YR