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

MAUDE Adverse Event Report: COVIDIEN PIPELINE EMBOLIZATION DEVICE 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
 

COVIDIEN PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77300-18
Device Problems Mechanical Problem (1384); Occlusion Within Device (1423)
Patient Problem No Code Available (3191)
Event Type  Injury  
Event Description

Information received from the article: fischer s, vajda z, aguilar m, et al. Pipeline embolization device (ped) for neurovascular reconstruction: initial experience in the treatment of 101 intracranial aneurysms and dissections. Neuroradiology (2012) 54:369¿382. Eighty-eight consecutive patients underwent pipeline embolization treatment between september 2009 and january 2011 for 101 intracranial aneurysms or dissections. Ninety-six aneurysms and five vessel dissections were treated. Multiple devices were implanted in 67 lesions. One mechanical failure was encountered in one procedure. Immediate exclusion of the target lesion was not observed. Angiographic follow-up examinations were done for 80 patients with 90 lesions revealing complete cure of the target lesion(s) in 47, morphological improvement in 32 lesions, and no improvement in 11 lesions. Six major complications were encountered: one fatal aneurysm rupture, one acute and one delayed pipeline thrombosis, and three hemorrhages in the dependent brain parenchyma. Patient (b)(6): the patient presented with symptoms of brainstem compression due to a large fusiform aneurysm of the basilar trunk. The patient underwent pipeline embolization treatment and contrast stagnation was observed within the aneurysm immediately after the deployment of two pipelines (3mm x 18 mm). The follow-up dsa (digital subtraction angiography) performed 8 months after the treatment demonstrated an incomplete occlusion of the aneurysm with a well reconstructed lumen of the basilar artery and patent anterior inferior cerebellar arteries (aicas). At 13 months, reperfusion of the aneurysm was found, which was related to the flow coming from the right vertebral artery (va), creating turbulent flow around the outer surface of the pipelines. The right v4 segment was, therefore, occluded with coils. On day 1 post treatment (14 months after ped treatment), the patient suffered a severe cerebellar hemorrhage, from which the patient recovered completely. The information was received from the same article as mdr# 2029214-2015-00023 / 2029214-2015-00015 / 2029214-2015-00016 / 2029214-2015-00020 / 2029214-2015-00018.

 
Manufacturer Narrative

The lot history record review was not possible since the lot numbers were not reported incomplete occlusion of the aneurysm with a well reconstructed lumen of the basilar artery and patent anterior inferior cerebellar arteries (aicas). Reperfusion of the aneurysm was found, which was related to the flow coming from the right vertebral artery (va), creating turbulent flow around the outer surface of the pipelines. The devices will not returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined. The other device involved in the event is as follows: model#: fa-77300-18 / lot#: not reported / dom: n/a / exp: n/a.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
IRVINE
9775 toledo way
irvine CA 92618
Manufacturer Contact
9775 toledo way
irvine, CA 92618
9496801558
MDR Report Key4398771
MDR Text Key5434827
Report Number2029214-2015-00014
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 12/09/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFA-77300-18
Device LOT NumberNOT REPORTED
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/09/2014
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 TREATMENT DATA
Date Received: 01/08/2015 Patient Sequence Number: 1
-
-