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

Model Number H74939200094070

Device Problems Bent (1059); Device Damaged by Another Device (2915)

Patient Problems Stroke/CVA (1770); Thrombosis (2100)

Event Date 03/26/2015

Event Type  Injury  

Event Description

Same case as mdr id 2134265-2015-02385.It was reported that stent damage, cerebrovascular accident and thrombosis occurred.Multiple lesions were identified.The first target lesion located in the right superficial femoral artery (sfa) was treated with an intra-aortic balloon pump (iabp).For the second lesion, vascular access was obtained via the left common femoral artery through a retrograde approach.The 75% stenosed, diffused target lesion was located in the common iliac artery (cia) to external iliac artery (eia).Predilation was performed and a 9x40x75 and a10x80x75 epic¿ vascular stents were implanted in an overlapping manner from the cia to the eia.Post dilation was then performed; both stents were well apposed to the vessel wall.In order to treat the opposite side of the sfa, a 6f non bsc introducer sheath was advanced using a dilator.The sheath was difficult to advance due to the angulation of the vessel and came in contact with the distal edge of the implanted 9x40x75 epic¿ vascular stent.As a result, about half of the epic stent was folded inwards.An attempt was made to perform intravascular ultrasound (ivus) for bailout, but the sheath was ¿redeployed to surface of the body¿ and unable to be inserted.Vascular access was then obtained via the right brachial artery through a non bsc guide sheath and a balloon catheter was used to dilate the folded portion of the 9x40x75 epic¿ vascular stent.Ivus was performed and the procedure was completed.The next day, the patient presented with thrombosis and stroke.The physician noted it was possible that the manipulation of the catheter via the brachial approach may have caused the thrombosis and stroke.The patient had symptoms of dizziness and double vision.No further patient complications were reported.

Manufacturer Narrative

(b)(4).Age at time of event: 18 years or older.  (b)(4).  device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• 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: 4723559
• MDR Text Key: 5743531
• Report Number: 2134265-2015-02250
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: H74939200094070
• Device Catalogue Number: 39200-09407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: GUIDE WIRE: 35 WIRE; INTRODUCER SHEATH: 6F DESTINATION
• Patient Outcome(s): Required Intervention