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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PIPELINE
Device Problem Communication or Transmission Problem (2896)
Patient Problem Fistula (1862)
Event Date 08/25/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). Article website: +http://casereports. Bmj. Com/content/2015/bcr-2015-011786. Long off label use: treatment of carotid¿cavernous fistula. Per instruction for use: the pipeline¿ embolization device (ped) is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments. Information regarding the device model and lot numbers, patient weight, and procedure complications have been requested; however, the authors have indicated that the information cannot be provided. The device will not be returned fro analysis as it was implanted in the patient. Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure complication.

 
Event Description

Medtronic (covidien) received information from literature review that a patient required another pipeline embolization device (ped) placement four months after the first ped implant due to persistent fistulous communication across the petrous cavernous junction. The patient was treated for a high flow, direct left carotid-cavernous fistula (ccf). A ped was deployed across the petrous-vernous carotid junction from a transarterial approach. A post-procedure angiogram showed near complete resolution of the ccf, with a few minor fistulous connections in the petrous segment of the internal carotid artery (ica). Four months later, a cerebral angiogram showed persistent fistulous communication across the petrous cavernous junction-aped was deployed into the left m1 segment of the middle cerebral artery in order to treat this abnormal communication. Seven months later, a repeat angiogram showed a completely remodeled ica and occlusion of the ccf. Citation: pradeep n, nottingham r, kam a, et al. Treatment of post-traumatic carotid-cavernous fistulas using pipeline embolization device assistance. Bmj case rep. 2015 aug 25;2015. Pii: bcr2015011786. Doi: 10. 1136/bcr-2015-011786.

 
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Brand NamePIPELINE
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 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine 92618
9496801224
MDR Report Key5088479
MDR Text Key26229766
Report Number2029214-2015-05003
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 HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 09/01/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPIPELINE
Device LOT NumberASKU
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 Received09/01/2015
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 Initial

Patient TREATMENT DATA
Date Received: 09/18/2015 Patient Sequence Number: 1
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