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

Catalog Number	PRB35-06-080-120
Medical Device Problem Codes	Accessory Incompatible (1004); Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient had a previous pta in the right common iliac artery with an unknown device, during a follow-up check the angiogram showed a small dissection in the right common iliac artery.The physician intended to use the protégé everflex to treat the dissection in the common iliac artery as per ifu.It was reported the vessel was pre-dilated.The stent was loaded on a 0.035¿ guidewire, and was advanced through a 6fr sheath.The device became stuck in the sheath, a second attempt was made to advance the device unsuccessfully.The 0.035¿ guidewire was changed for another 0.035 guidewire, the same advancement issues remained.The physician pulled back the delivery system and observed a break in the shaft, the stent was not mounted on it.The physician pulled back the sheath, cutting it with a knife, revealing the stent inside the sheath.Physician decided not to stent the patient as the blood flow was good.No injury to the patient reported.
Additional Manufacturer Narrative
Evaluation summary: visual inspection: the green non-medtronic sheath was inspected.The green outer jacket of the sheath was cut approximately 10.5 cm from the sheath tip.The metal coiled portion of the sheath was intact, however stretched out.Approximately 44cm of the coil was noted between the cut segments of the sheath jacket.The proximal segment of the sheath showed a bend approximately 3cm from the cut distal end.The distal segment showed the rim of the distal tip bent inwards.Direct backlighting was applied to the sheath and a stent could not be observed within the lumen of the sheath.The protégé everflex was returned with the safety locking pin tightened.The unit was inspected and observed the catheter was bent/twisted approximately 15cm from the distal tip.An approximate 90-degree bend to the catheter shaft was noted at approximately 120cm from the distal tip, at the area of the distal rim of the strain relief.The safety pin was loosened.The deployment grip was started to be pulled and it could be seen that the stent was loaded.Damage to the sheath and everflex deployment system would have led to difficulty in pulling the device through the sheath.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7091467
• Report Number: 2183870-2017-00547
• Device Sequence Number: 19306652
• Product Code: NIO
• UDI-Device Identifier: 00821684069202
• UDI-Public: 00821684069202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• 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,Followup
• Report Date (Section B): 01/18/2018

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: 09/09/2019
• Device Catalogue Number: PRB35-06-080-120
• Device Lot Number: A341316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 01/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 108