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

Catalog Number EVR35-06-060-080

Device Problem Inaccurate Delivery (2339)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/31/2017

Event Type  Injury  

Event Description

The physician was attempting to use a everflex stent with entrust delivery system to treat a lesion in the right proximal cfa.The target lesion was moderately calcified, 40 mm and had 50% stenosis.The artery had little tortuosity and was 5.5 mm in diameter.There were no abnormalities reported in relation to the patient¿s anatomy.The device was prepped as per the ifu with no issues identified.No damage was noted to the device or it's packaging.The procedure utilized a 6 fr 11 cm sheath and a guidewire.Embolic protection was not used.The lesion was pre-dilated to 5mm.The device was not passed through a previously deployed stent and no resistance was encountered upon advancement, excessive force was not used.It was reported that the surgeon successfully placed the undeployed stent delivery system within the lesion margins prior to deployment, and there was sufficient distal landing zone.During deployment, the stent jumped forward and it was reported that the delivery system had to be forced to stay in place and that it was difficult to control this adequately.As a result, the stent jumped forward and was inaccurately deployed outside of the target site.The proximal end of the stent landed in the middle of the target lesion.The stent deployment system was safely removed and a second everflex entrust was successfully deployed to adequately cover the lesion and complete the procedure.Angiographic latency results were satisfactory.No patient injury reported.

• 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: 6904395
• MDR Text Key: 87779943
• Report Number: 2183870-2017-00421
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2019
• Device Catalogue Number: EVR35-06-060-080
• Device Lot Number: A331268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2017
• Date Device Manufactured: 08/19/2016
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 59