MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Citation: brendan d.Killory, kent j.Kilbourn, martin ollenschleger."a novel use of direct platelet application during surgery for clopidogrel-associated intracerebral hemorrhage" world neurosurg.(2015) 84, 6:2078.E1-2078.E4.Http://dx.Doi.Org/10.1016/j.Wneu.2015.08.016 the device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patient post procedure and its cause was unknown.

Event Description

Medtronic received information through literature review that this patient experienced a large right temporal intracerebral hematoma 14 days after implant of two pipeline devices.It was reported that a this patient presented with an intradural right vertebral artery dissection with a ruptured 6-mm pseudoaneurysm.The patient was started on aspirin and clopidogrel and the vessel was reconstructed with 2 pipeline embolization devices.On postbleed day number 14, she became obtunded with a blown right pupil; computed tomography of the head demonstrated a large right temporal intracerebral hematoma.The patient was taken emergently to the operating room for evacuation of the clot.Intraoperatively, satisfactory control of bleeding was not achieved despite transfusing several units of platelets intravenously.Ultimately, a mixture of floseal and platelets applied directly to the hematoma wall allowed prompt hemostasis.At 3 months the patient was doing extremely well clinically and angiography demonstrated occlusion of the aneurysm.

Manufacturer Narrative

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

• Brand Name: PIPELINE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MEDTRONIC COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 5773801
• MDR Text Key: 48918304
• Report Number: 2029214-2016-00513
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR