MAUDE Adverse Event Report: COVIDIEN PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD; STENT, ILIAC

Catalog Number	SERB65-10-40-80
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the protégé gps stent delivery system was received for evaluation with the distal deployment paddle separated from the manifold cap.The separation is between the manifold cap and the lock housing.The stainless steel hypotube does not exhibit signs of excessive forces being applied to it.The outer sheath appears to be pulled backed from the distal tip of the stent delivery system with the distal marker hoops of the stent exposed but not flowered.Crystalline residue was noted within the stopcock tube indicating that the device had been prepped.The stent was deployed from the stent deployment system by pinning the proximal deployment paddle and pulling the outer sheath proximal by the manifold.The stent was covered with sanguine residue.No abnormality or deformity was noted in the stent structure.The inner distal assembly including the retainer was examined: no abnormality or deformity was noted.The inner distal assembly was cut off to allow better examination of the separation faces of the lock housing and manifold cap.The inner guidewire lumen and stainless steel hypotube were removed to allow examination of the separation faces of the lock housing and manifold cap.The sonic weld is almost completely welded circumferential, on the manifold cap.The sonic weld is almost complet ely welded circumferential, on the lock housing.
Event or Problem Description
The physician was attempting to use one protégé gps stent.The device was prepped as per the ifu with no issues noted.When the physician attempted to deploy the stent, a break/fracture occurred at the handle.The break occurred outside of the patient.The undeployable stent was removed and another stent placed to complete the procedure.No patient injury reported.

• Brand Name: PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6606713
• Report Number: 2183870-2017-00232
• Device Sequence Number: 1089473
• Product Code: NIO
• UDI-Device Identifier: 00821684071540
• UDI-Public: 00821684071540
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P060001
• 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): 05/04/2017

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: 08/10/2018
• Device Catalogue Number: SERB65-10-40-80
• Device Lot Number: A145593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 06/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1