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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77475-20
Device Problems Delamination (2904); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Seizures (2063)
Event Date 09/23/2016
Event Type  Injury  
Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post-procedure and its cause could not be conclusively determined from the reported information.

 
Event Description

Medtronic received report that a patient experienced cerebral edema after pipeline implantation. Patient underwent flow diversion treatment of a blister aneurysm; a pipeline device was implanted. One month post-procedure, angiography showed good results. Two months post-procedure, the patient had focal right convulsive crisis. Cerebral arteriography showed that cortico-subcortico vasogenic edema in left hemisphere, mainly in border zones suggestive of inflammatory process.

 
Manufacturer Narrative

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.

 
Manufacturer Narrative

Additional information the pipeline device performed as intended as indicated by successful implantation in the treatment of a blister aneurysm. There were no reports of device issues during the implantation procedure. The pipeline will not be returned for evaluation as it remains implanted in the patient. Product analysis cannot be performed. It was reported that two months post-procedure, the patient experienced a focal right convulsive crisis. Cerebral arteriography showed edema in the left hemisphere. The patient received corticoid therapy with dexamethasone and anticonvulsant. The patient is currently asymptomatic with improvement in image examination, presenting only signs of contrast uptake and edema reduction. An independent medical review was sought to investigate the customer¿s allegation of ptfe relationship to the event. Review of the provided images (select angiographic, mr, and ct images) could not confirm the customer¿s allegation of pipeline ptfe embolization. Because the patient presented with clinical symptoms approximately two months after pipeline implantation, ptfe embolization would be an unlikely culprit for the adverse event. Only the core wire of the pipeline delivery system contains ptfe; the implantable portion of the pipeline device does not contain any ptfe. If ptfe delamination were the cause of the post-procedure symptoms, the ptfe would have most likely been released at the time of pipeline implantation; it would seem unlikely to then cause no symptoms for several months. It should be noted that this clinical scenario (delayed symptoms) has been reported in other cases and has presumed to be due to embolization of hydrophilic polymer fragments from catheters¿ polyvinyl propylene. The provided images are inconclusive regarding a potential relationship between the vasogenic edema and possible embolization of ptfe. A relationship between possible ptfe embolization and the patient¿s delayed hypersensitivity reaction cannot be confirmed; in addition, contribution of ptfe cannot be ruled out given the information available.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
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Brand NamePIPELINE EMBOLIZATION DEVICE
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
9496801224
MDR Report Key6140207
MDR Text Key61289910
Report Number2029214-2016-01083
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/16/2017
Device MODEL NumberFA-77475-20
Device LOT NumberA018470
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 Received05/08/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/17/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number2029214-10/7/16-001-R

Patient TREATMENT DATA
Date Received: 12/01/2016 Patient Sequence Number: 1
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