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

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

Patient Problems Infarction, Cerebral (1771); Foreign Body Reaction (1868); Thrombosis (2100)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

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.Citation: c.Iosif et al "middle cerebral artery bifurcation aneurysms treated by extrasaccular flow diverters: midterm angiographic evolution and clinical outcome" american journal of neuroradiology - 2016.Http://dx.Doi.Org/10.3174/ajnr.A5022.

Event Description

Medtronic received information through review of literature that in this cohort the patients were treated with flow-diversion devices, clinical mrs outcomes at discharge from the hospital were 0 for 12 patients, 1 for 41 patients, 2 for 3 patients, and 2 for 2 patients.During the post-procedure hospitalization, 4 patients developed procedure related ischemic events.One patient, with a giant aneurysm, developed a perianeurysmal brain inflammatory reaction in the fourth postprocedural week, which progressively resolved under steroids.One patient developed ischemic stroke at 3 months postintervention following discontinuation of clopidogrel without consulting the physician.Among the patients who had ischemic events or transient symptoms, 4 were treated with clopidogrel and 1, with a prasugrel regimen.There were reportedly 5 procedure-related morbidity.Periprocedural thrombus formation was encountered in 4.8% 3 of the cases; the latter was clinically evident as worsening of the clinical situation on awakening in 1 case and resulted in an increase of 2 points on the mrs score at discharge.In a 5-year period, 58 consecutive patients (17 men, 41 women; mean age, 52.4 years with 63 middle cerebral artery (mca) bifurcation aneurysms were included in this study.Fifty-seven aneurysms were treated with the pipeline embolization device and six were treated with a competitor¿s device.Most of the aneurysms were treated with single flow diversion (fd) coverage (58/63, 2 were covered in a telescopic fashion and there was adjunctive use of coils due to the large size for 3 aneurysms.In 3 other cases of single-fd coverage, the fd was deployed in a previously existing conventional intracranial stent.

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: 6609682
• MDR Text Key: 76589711
• Report Number: 2029214-2017-00726
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100018.S004
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• 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: 05/05/2017
• 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; Disability
• Patient Age: 54 YR