MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number	EVD35-06-120-120
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use one exerflex stent to treat a lesion located in the sfa.The device was removed from its packaging, prepped per the ifu and inspected with no issues noted.The lesion was pre-dilated.It was reported that when the physician successfully positioned the device, the red barrier was removed but when they began turning the dial to deploy it clicked 3 times, however the stent would not deploy.When they tried to bring it back over the wire, the two were stuck together.In the end, everything was removed.The physician then regained access and finished the procedure using a dcb.Later the stent would not deploy when tested.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the everflex entrust stent delivery system (sds) was received for evaluation.The everflex entrust sds was received locked up on the 0.018¿ guidewire, approximately 30mm of the 120mm stent was deployed, and the red safety locking tab/tube was received removed from the handle of the sds.Backlighting was used to confirm the location of the proximal end of the stent and distal end of the pushrod/inner guidewire lumen.The proximal end of the 120mm stent was in contact with the distal end of the pushrod/inner guidewire lumen.The handle was examined: the inner guidewire lumen exhibited accordion folding within the safety tab cavity of the handle.The printed strain relief was removed from the distal tip of the handle.The handle was split open along its separation line.The pull cable was properly routed and still attached to the thumb wheel.The inner guidewire lumen accordion fold appears to be a tight ¿z-kink¿.The proximal end of the ¿z-kink¿ was cut.The proximal segment of the guidewire was able to be removed from guidewire lumen.The distal segment of the guidewire could not be removed from the guidewire lumen.The distal end of the ¿z-kink¿ was cut just distal of the last sign of accordion folding of the inner guide wire lumen.The distal segment of the guidewire was able to be removed from the catheter.The distal segment is approximately 154.7cm in length and has a double kink approximately 124.7cm and 128.2cm from its distal tip.The guidewire segment within the tight ¿z-kink¿ could not be removed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6586638
• Report Number: 2183870-2017-00221
• Device Sequence Number: 16165843
• Product Code: NIP
• UDI-Device Identifier: 00821684051382
• UDI-Public: 00821684051382
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/17/2017

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: 05/23/2019
• Device Catalogue Number: EVD35-06-120-120
• Device Lot Number: A282477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 07/17/2017; 07/17/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 08/15/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR