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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-30
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage, Subarachnoid (1893); Perforation (2001); No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2018
Event Type  Death  
Manufacturer Narrative
The pipeline was not returned as it was implanted in the patient. The cause of the hemorrhage and death cannot be reliably determined; however, per the reported information and review of ifu, the most likely cause of the event was the procedure, medication and patient condition. Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the pipeline device occurred during the treatment procedure. There is no evidence suggesting that the device was defective, but rather a procedure related event. However, the exact cause of the hemorrhage and death remain unknown. Hemorrhage and death are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the patient experienced a serious subarachnoid hemorrhage (sah), suspected m1/2 junction vessel perforation by ped tip coil. Contrast leakage in m1/2 junction, showed vessel bleeding. The tip coil of the ped was suspected to have perforate the vessel during deployment from microcatheter. The aneurysm was in the left internal carotid artery (ica) ophthalmic region. The aneurysm was unruptured, saccular, with a max diameter of 23. 6mm and a neck diameter of 10mm. The distal and proximal landing zones were both 10mm. The anatomy was moderate in tortuosity. Patient age was reported to be around (b)(6) and was diagnosed with a left ica, ophthalmic, giant aneurysm (dome size 23. 6mm). Bi-axial approach was planned with loose packing of 2 axium complex and pipeline flex across the aneurysm neck. The tip of the microcatheter was positioned at m1/2 region and vessel perforation was suspected during protrusion of ped tip-coil. Contrast leakage was observed under dsa and two more flow diverters (fred jr. Microvention/ competitor devices) were placed within the bleeding location across the m1/2 region. The patient was reported to have expired 3 days post the initial procedure. The death was alleged to have been a result of the sah.
 
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Brand NamePIPELINE FLEX
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
9492753836
MDR Report Key7545576
MDR Text Key109293800
Report Number2029214-2018-00456
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-350-30
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 Received05/01/2018
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: 05/25/2018 Patient Sequence Number: 1
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