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

Device Problems Stretched (1601); Failure to Fire (2610)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/01/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use an everflex entrust.It was reported that stent deformation occurred in vivo during positioning/deployment and excessive force was used during delivery.It was reported that the tip of the stent was deployed but then the thumb wheel jammed.The thumbwheel was manipulated and it broke leaving the stent in the shaft with only the tip deployed.The handle was broken open and the stent was deployed manually.It was noted that the stent was elongated and another stent was deployed inside of the everflext entrust stent.

Manufacturer Narrative

Device evaluation the everflex entrust stent delivery system, (sds), was received for evaluation loosely coiled with the handle disassembled within a large red biohazard bag.No ancillary devices from the procedure were received for evaluation.The handle was received split into its two halves, thumbwheel and pulley loose along with the red safety tab and tube.The catheter is coiled, has several kinks along its length, and the blue isolation sheath/strain relief pulled proximally until it is touching the guidewire lumen proximal hub.The distal ends of the two handles halves were examined: no unusual wear marks from the pull cable were present.This indicates that the pull cable was properly routed.The proximal hub on the guidewire lumen was cut-off to allow further examination of the guidewire lumen.Once the hub was removed the isolation sheath was slid off the guidewire lumen.The guidewire lumen was placed in its groove in the handle a series of accordion folds/kinks in the guidewire lumen were noted just distal of the handle¿s safety tab cavity.The accordion folds/kinks are an indicator that the guidewire used during the procedure did not provide enough support.A kink in the guidewire lumen was noted just proximal of the proximal end of the silver outer sheath.This kink most likely happened post-procedure given how the device was packaged for return.The pull cable appears to have broken proximal to the outer sheath.The distal end of the catheter¿s outer sheath was examined: the distal end appears to be ovalized.Backlighting indicated the presence of sanguine residue within the outer sheath.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: 8334693
• MDR Text Key: 135994711
• Report Number: 2183870-2019-00070
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other