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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-71500-35
Device Problem Activation Failure (3270)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
Griauzde, j. , ravindra, v. M. , chaudhary, n. , gemmete, j. J. , mazur, m. D. , roark, c. D. ,. Pandey, a. S. (2017). Use of the pipeline embolization device in the treatment of iatrogenic intracranial vascular injuries: a bi-institutional experience. Neurosurgical focus, 42(6). Doi:10. 3171/2017. 3. Focus1735 the pipeline device has not been returned for evaluation as it remains implanted in the patient; product analysis cannot be performed. The report of suboptimal wall apposition cannot be performed; the cause of suboptimal wall apposition cannot be conclusively determined from the reported information. It should be noted that the pipeline device is not indicated for use in the treatment of vessel dissections. Per the instructions for use, "the ped is intended for endovascular embolization of cerebral aneurysms. " a good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found a report of suboptimal wall apposition after pipeline placement. The purpose of this article was to report the experience with the use of the pipeline embolization device (ped) for the treatment of iatrogenic intracranial vascular injuries. The article states that in case 3, the patient was undergoing resection of a recurrent pituitary macroadenoma. After resection, brisk bleeding was encountered from the right internal carotid artery (ica). Cerebral angiography demonstrated disintegration of the right ica at the distal cavernous segment proximal to the anterior genu with contrast extravasation and injury to the intima with narrowing and dissection of the vessel. A ped was placed proximal to the ophthalmic artery to the distal petrous segment. The article states that there was suboptimal wall apposition and continued extravasation from the segment, likely because of the nature and size of the vessel injury. The vessel was sacrificed using coil embolization, trapping the injured segment with coils from proximal to the ophthalmic artery to the distal petrous segment.
 
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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 Key6685127
MDR Text Key79025126
Report Number2029214-2017-00850
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.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 06/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFA-71500-35
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 Received06/09/2017
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 Initial

Patient Treatment Data
Date Received: 07/03/2017 Patient Sequence Number: 1
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