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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aneurysm (1708); Calcium Deposits/Calcification (1758); Infarction, Cerebral (1771); Transient Ischemic Attack (2109)
Event Type  Injury  
Manufacturer Narrative
The device was not returned as it was successfully implanted in the patient. Attempts have been made to obtain additional information, however, our attempts have been unsuccessful. Thrombus formation is a 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 pipeline device occurred during the treatment procedure. There is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related event. The exact cause is remains 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 5 days post the ped treatment, the patient experienced a left anterior stroke. A thrombectomy attempt with aspiration only was not successful. This was probably a case of ticagrelor resistance. The aneurysm was in the pcom. There was calcification at the neck. Aneurysm size was 17 mm (height) x 4 mm (neck). Ticagrelor (180 mg) is administered pre-op.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7720187
MDR Text Key115059406
Report Number2029214-2018-00656
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
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
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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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