• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC COVIDIEN PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
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
If information is provided in the future, a supplemental report will be issued.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE
Type of DeviceINTRACRANIAL 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 Key6609682
MDR Text Key106995192
Report Number2029214-2017-00726
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received06/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/02/2017 Patient Sequence Number: 1
-
-