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

Catalog Number EVX35-06-040-150

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2018

Event Type  malfunction  

Manufacturer Narrative

The everflex entrust device involved in this event was not returned for evaluation.One photograph was received.The as reported information provided indicates the everflex entrust was used with a 6f non-medtronic sheath and 0.018¿ non-medtronic guidewire.The product labeling affiliated with lot a667818 indicates compatibility with 5f sheaths and 0.035¿ guidewires.The photo received shows two everflex entrust units.One unit was used as a comparison and the other shows the alleged missing end piece.Both units in the photo show the red locking pin removed.The everflex unit on the right side (the reported failed device) showed the blue isolation sheath separated from the handle assembly.No clear connector was observed at the proximal end of the isolation sheath.It should be noted however, beneath the gray strain relief could not be inspected.The clear connector was not visible and is not expected to be visible during intended use.The everflex entrust devices are manufactured with the connector located beneath the gray strain relief and the proximal end of the connector is seated inside the handle assembly.The pull cable was identified between the handle assembly and the isolation sheath.The exposed inner assembly showed an approximate 90-degree bend between the handle assembly and the isolation sheath.No portion of the stent was visible outside the distal end of the everflex entrust catheter shaft.The photograph does not show any component of the everflex entrust missing.The blue isolation sheath can be seen detached from the handle assembly without the connector being visible.It is not possible to visualise, from a photograph, if the clear connector remains beneath the gray strain relief.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use the everflex entrust.It was reported the everflex was advanced to the lesion, the safety pin was removed and the thumb switch operated correctly.It was observed that the stent did not release but the blue band protection.In addition, a tension wire was visible distal to the handpiece.It was reported that the blue end piece of the device was missing.The stent could not be released.The device was removed from the patient with difficulty.No harm to the patient was reported.

Manufacturer Narrative

Evaluation summary: the everflex entrust was returned for evaluation.No ancillary devices were included.Visual inspection: the everflex entrust was inspected.The blue strain relief was disengaged from the handle assembly.The inner catheter was exposed and folded over.It was observed the red locking pin was removed from the handle assembly and was not included with the returned device.Direct lighting was applied to the distal end of the catheter shaft and it was verified that the stent remained loaded on the catheter.The catheter shaft showed a bend approximately 16.5cm from the distal tip.The gray strain relief was cut in order to inspect the distal end of the handle assembly.It was verified that the clear connector was present and located at the base of the handle assembly.Traces of dried adhesive were noted around the distal rim of the connector.Traces of adhesive were also noted on the exterior of the blue strain relief approximately 1.3cm from the proximal end.Functional testing: the thumb wheel was able to rotate and the pull cable was capable of being withdrawn into the handle assembly.The exposed inner contributed to resistance after the slack was removed and could not enter the handles assembly.The stent could not deploy.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8110805
• MDR Text Key: 129155037
• Report Number: 2183870-2018-00541
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2021
• Device Catalogue Number: EVX35-06-040-150
• Device Lot Number: A667818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1