MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EPIC¿ VASCULAR; STENT, ILIAC

Model Number H74939200061020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Edema (1820); Pain (1994); Thrombosis (2100)

Event Date 05/27/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) age at time of event: 18 years or older.Device evaluated by mfr: the complaint device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-05976.It was reported that the patient died.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).Vascular access was obtained using retrograde approach from right sfa.Intravascular ultrasound was attempted but the device could not pass through.A 2.0x40 coyote balloon catheter was then used to expand the external iliac artery (eia) at 12 atmospheres and then a 6.0x40 sterling at 6 atmospheres.The blood flow was bad which confirmed by antegrade contrast radiography.The physician then decided to do stenting.An 6x100x120 epic was then deployed near sfa and another 8.0x60 epic stent was also deployed.Few hours after the procedure, the patient complained about swollen leg and pain.Subsequently, an emergency treatment was held.It was then noted that a thrombus occurred which was treated with by implanting a non-bsc stent.The procedure had difficulty and took hours, however, was finished without any issue.On the following day, in the morning, the patient had cardiac arrest and eventually died due to hemostasis.

• Brand Name: EPIC¿ VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5742303
• MDR Text Key: 47948321
• Report Number: 2134265-2016-05977
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: H74939200061020
• Device Catalogue Number: 39200-06102
• Device Lot Number: 18394001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• 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): Death