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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PED-250-18 INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PED-250-18 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-250-18
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Occlusion (1984); No Code Available (3191)
Event Date 05/18/2018
Event Type  Injury  
Manufacturer Narrative
The device was not returned as it was implanted in the patient. Attempts have been made to obtain additional information. However, our attempts have been unsuccessful. Thrombus formation and dissections/ injuries are known inherent risk of the endovascular procedures and is documented in our devices¿ instructions for use (ifu). Based on the reported information, there was no reasonably suggestion that a malfunction or quality deficiency of the devices occurred during the treatment procedure. There is no evidence suggesting that the devices were defective, but rather a procedure and patient condition related event and the exact cause is unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the following report through a health care professional conference. One case that was presented stated that 18 months after the uneventful the pipeline embolization procedure, the pipeline was alleged to have been occluded. This event was treated with 9f cello and 3 max (aspiration only). A dissection was alleged to have occurred because of the cello being in the carotid, wh ich was subsequently stented. The aneurysm was in the left pcom, which recurred after 6 months post initial coil treatment. Prior to the procedure, the patient was on asa only for 10 days with no issues.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePED-250-18
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
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7720544
MDR Text Key115060570
Report Number2029214-2018-00657
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,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-250-18
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No
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: 07/25/2018 Patient Sequence Number: 1
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