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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-425-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Neurological Deficit/Dysfunction (1982); Paralysis (1997)
Event Date 10/22/2015
Event Type  Injury  
Manufacturer Narrative
The pipeline was not returned for analysis as it was implanted in the patient. Based on the reported information, there was no allegation that a malfunction or deficiency of the implanted device occurred during the embolization procedure. The exact cause of the reported events is unknown. Neurological deterioration is a known inherited risk of endovascular embolization procedures and is documented in the instruction for use (ifu). Based on the reported information, there is no evidence suggesting that the pipeline was defective, but rather a post procedure and patient condition related event. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that post the procedure, the patient developed word finding difficulty, paresthesia, and dizziness. The cause was reported to have been unknown and continuing. The patient received the pipeline flex to treat a saccular aneurysm in the left, c6 internal carotid artery (ica). The aneurysm dome was 2. 8mm and neck diameter was 3. 0mm. There was no report of any device issue during the procedure. Full wall apposition was achieved. The patient¿s mrs was 1 at screening and discharge;mrs was 0 at 30-day and 180-day follow ups. The patient¿s nihss was 1 at procedure, discharge, and follow ups.
 
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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 Key7632775
MDR Text Key112137736
Report Number2029214-2018-00578
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/21/2017
Device Model NumberPED-425-16
Device Lot NumberA052266
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 Received06/08/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/22/2014
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: 06/24/2018 Patient Sequence Number: 1
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