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

Model Number PED-475-25

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

Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

The reported product remains implanted in patient; therefore, product analysis could not be performed.As a result, the cause of the clinical observation could not be conclusively determined.Linked mdr 2029214-2017-01043 2029214-2017-01044 2029214-2017-01045 2029214-2017-01046 2029214-2017-01047 2029214-2017-01048 2029214-2017-01049 2029214-2017-01050 2029214-2017-01051 2029214-2017-01052 2029214-2017-01053 2029214-2017-01054 2029214-2017-01055 2029214-2017-01056 2029214-2017-01057 2029214-2017-01058 2029214-2017-01059.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that a patient experienced internal carotid artery in-stent thrombosis 5 hours after a pipeline flex flow diversion treatment for a saccular aneurysm located at paraclinoid segment.It was reported the pipeline covered the aneurysm neck.Ischemic signs were observed at the distal end of the pipeline.A clot had formed inside the pipeline flow diverter.The patient's internal carotid artery was occluded and the patient had decrease level of consciousness.Thrombectomy by surgical aspiration and fibrinolytic agent were performed for this patient, the internal carotid artery was re-perfused.Two days after the initial flow diversion procedure, the patient had decreased level of consciousness caused by hemorrhage from the aneurysm neck.The patient was treated with placement of two additional flow diverters connected to the initial flow diverter.

Manufacturer Narrative

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

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9496801224
• MDR Report Key: 6871269
• MDR Text Key: 86428477
• Report Number: 2029214-2017-01043
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• 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,Followup
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: PED-475-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• 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: 50 YR