MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; EPIC STENT 6X120

Model Number EPIC

Device Problem Structural Problem (2506)

Patient Problems Pain (1994); Tissue Damage (2104); Disability (2371); Vascular System (Circulation), Impaired (2572)

Event Date 08/14/2015

Event Type  Injury  

Event Description

Diagnosis -total occlusion right superficial femoral artery.On (b)(6) 2015 - underwent catheter based reconstruction and angioplasty right leg.On (b)(6) 2015 - acute right lower extremity arterial thrombosis, underwent right lower extremity revascularization with right superficial femoral artery stenting x 5, epic stent self expanding x4 and balloon expandable chorda stent x 1.As first stent deployed in distal superficial femoral and popliteal arteries, there was some type of manufacturing defect with stent malfunction.Within a few minutes, a second balloon expandable stent was inflated inside the previous stent with excellent blood flow confirmed.The patient was discharged home.Patient returned to facility several hours later on (b)(6) 2015 with complaint of right leg pain.Patient underwent angiogram and tpa lysis infusion of right lower extremity on (b)(6) 2015.Multiple subsequent attempts were made at re-vascularization during hospitalization.On (b)(6) 2015, patient underwent a right below the knee amputation.On (b)(6) 2015, patient underwent a right above the knee amputation.Patient was discharged several days later.Event occurred on (b)(6) 2015.Vendor notified on (b)(6) 2015.Risk manager aware on (b)(6) 2015.Initially reported and believed to be a "kink" in stent upon deployment.Due to timeliness of identification of stent defect and new stent deployment, it was not thought to be related to the outcome.At initial mdr meeting on (b)(6) 2015, it was determined not be reportable.Physician not available until (b)(6) 2015 at which time a discussion with surgeon revealed that although patient has significant co-morbidities and pre-existing vascular disease, it could not be determined what impact this event had on patient's outcome.Decision was made to report at this time.Ref mfr# 2134265-2015-07567, 7568, 7566, 6948.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: EPIC STENT 6X120
• Manufacturer (Section D): BOSTON SCIENTIFIC; 1 boston scientific place; natick MA 01760
• MDR Report Key: 5184774
• MDR Text Key: 29868381
• Report Number: 5184774
• Device Sequence Number: 1
• Product Code: NIO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EPIC
• Device Catalogue Number: 39200-061220
• Device Lot Number: 18135895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/09/2015
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 105