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

MAUDE Adverse Event Report: COVIDIEN (IRVINE) 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 (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Occlusion Within Device (1423)
Patient Problems Failure of Implant (1924); Visual Disturbances (2140)
Event Date 12/01/2013
Event Type  Injury  
Event Description

Medtronic (covidien) received information from literature review that a patient experienced multiple branch retinal artery occlusions (braos) three weeks after pipeline embolization device placement. The patient underwent flow diversion treatment of an aneurysm at the anterior genu of the left internal carotid artery, opposite to the origin of the left ophthalmic artery. The patient was treated with 2 pipeline devices telescoped from the origin of the left posterior communicating artery to the vertical segment of the petrous portion of the left internal carotid artery covering the entire length of the aneurysm. There were no reported intraoperative or immediate postoperative complications, and postprocedure angiography of the parent and branching vessels appeared normal. The patient was discharged on clopidogrel and aspirin. Three weeks after the procedure, she presented to the emergency department with sudden, painless vision loss in her left eye. Emergent computed tomography, mri, and mra of the head and neck revealed no acute abnormalities, expected artifact from the pipeline device, and no evidence of aneurysmal filling. The patient refused cerebral angiography. P2y12 and aspirin reaction units were within normal limits. The patient was diagnosed with multiple branch retinal artery occlusions (braos) and instructed to continue her aspirin and clopidogrel. Cerebral angiography performed during routine 6-month follow-up showed patent flow through the pipeline devices and complete obliteration of the aneurysm, with some narrowing of the proximal pipeline device at its proximal and distal ends. The left ophthalmic artery filled through the walls of the pipeline devices, and there was an intact choroidal blush of the left eye. The patient's visual acuity stabilized at 20/20 bilaterally, with a dense visual field defect in the right eye. Tha author explained it is presumed that the narrowing of the second pipeline device may have caused a disruption of flow into the ophthalmic artery, or thrombus, that embolized distally into the retinal arterioles. The cause of the narrowing is unclear, and although the use of angioplasty to widen the areas of stenosis was considered, ultimately this was dismissed because of the patient's stable clinical course. Citation: sise, ab. Osher, jm. Kolsky, mp, et al. Pipeline embolization device: a new source for embolic retinal vascular occlusion. Journal of neuro-ophthalmology. 33(4):373-376, december 2013.

 
Manufacturer Narrative

Citation: sise, ab. Osher, jm. Kolsky, mp, et al. Pipeline embolization device: a new source for embolic retinal vascular occlusion. Journal of neuro-ophthalmology. 33(4):373-376, december 2013. Article website: http://www. Ncbi. Nlm. Nih. Gov/pubmed/24051422. The lot history record review was not possible since the lot numbers were not reported. The devices will not be returned for analysis as they were implanted in the patient; therefore, the event cause could not be determined.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key4683854
MDR Text Key5675025
Report Number2029214-2015-00370
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
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 03/16/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2015
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 Received03/16/2015
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: 04/13/2015 Patient Sequence Number: 1
-
-