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

Catalog Number	SERB65-10-80-120
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	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: only one of the protégé gps stent delivery system was received for evaluation.No cine images from the procedure were received for e valuation.The protégé gps sds was received with a separation of the manifold lock housing from the manifold cap.The deployment paddles were in close proximity to each other, the outer sheath was received retracted from sds distal tip, and the sds was received without a stent.The sds inner distal assembly was cut from the sds just proximal to the stent retainer to allow the removal of the inner guidewire lumen.With the inner guidewire lumen removed the distal paddle/lock housing separation face was examined: an incomplete sonic weld was noted.The manifold cap to lock housing separation face was examined: an incomplete sonic weld was noted.
Event or Problem Description
The physician was attempting to use a protégé gps stent to treat an unknown lesion.The device was prepped as per ifu without issue.No resistance was encountered when advancing the device and no excessive force was used the thumbscrew/lock-pin was checked for measurement prior to procedure.Prior to attempting to deploy the stent, when unscrewing the pin pull deployment, it was reported that the whole assembly came apart.A second protégé gps stent was used to complete the procedure.It was reported that similar issues were encountered with the second stent also, but that the physician managed to successfully deploy the stent.No patient injury was 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: 6574260
• Report Number: 2183870-2017-00214
• Device Sequence Number: 142732
• Product Code: NIO
• UDI-Device Identifier: 00821684071571
• UDI-Public: 00821684071571
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2017

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: 12/21/2019
• Device Catalogue Number: SERB65-10-80-120
• Device Lot Number: A392909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1