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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-450-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Neurological Deficit/Dysfunction (1982)
Event Date 12/22/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device was reported to have performed as intended; as indicated by successful deployment, therefore it was not returned. No treatment was reported to have been required for the vision event or for the mass effect. Neurological deficits are known inherent risk of intracranial procedure and are documented in the devices instruction for use. Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event. There is no evidence suggesting that the device was defective. The patient's clinical status did improve as evident by mrs of 1 from 2. Per the reported information, and review of ifu, the most likely cause for the worsening of mass effect and vision issue may have been changes in the flow of blood. However, an exact caused cannot be determine.
 
Event Description
Medtronic received report that post procedure, the patient had eye movement disorder and the mass effect worsen. The aneurysm was in the right ic-cavernous, unruptured, saccular, with size: max diameter 19. 0 mm, neck width 16. 0 mm. Baseline mrs was 0. On the 4th day post intervention, the patient was reported to have mrs: 2 (mass effect: yes (got worse)). At 6 month follow up the mrs was 1 and the vision issue had resolved but the mass effect remained.
 
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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 Key6586629
MDR Text Key106866768
Report Number2029214-2017-00695
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 foreign,health professional,s
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/20/2018
Device Model NumberPED-450-35
Device Lot NumberA150539
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 Received04/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/21/2015
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: 05/23/2017 Patient Sequence Number: 1
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