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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 Problem Hemorrhage/Bleeding (1888)
Event Date 04/25/2016
Event Type  Injury  
Manufacturer Narrative
The pipeline device will not be returned for investigation as it was implanted in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.The event occurred in the patients post procedure and its cause was unknown.Additional information has been requested on this reported event, however, no response has been received.Should it become available a supplemental report will be submitted.¿ 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 received information that post procedure embolization treatment with pipeline, the patient had small to medium level bleeding on the same day.The patient was recovered after one week later.The patient received this embolization treatment of an ic-piarachnoid, right, unruptured, fusiform, aneurysm with max diameter and neck width of 10.4 mm and 6.7 mm respectively one year ago.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL 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
9498373700
MDR Report Key6540093
MDR Text Key74281078
Report Number2029214-2017-00617
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/16/2018
Device Model NumberPED-425-16
Device Lot NumberA091557
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/10/2017
Initial Date FDA Received05/03/2017
Supplement Dates Manufacturer Received04/10/2017
Supplement Dates FDA Received10/03/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/17/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
Patient Weight45
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