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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATIN DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number FA-77475-18
Device Problem Flaked (1246)
Patient Problems Infarction, Cerebral (1771); No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2015
Event Type  Injury  
Event Description

Medtronic (covidien) received information that during a flow diversion treatment of an unruptured saccular internal carotid artery (ica) aneurysm using a pipeline embolization device, the physician noticed a coating on the wire had flaked and stripped off in several locations along the length of the wire. The physician loaded the guidewire and the catheter at the same time and reported no resistance encountered when delivering the pipeline. The pipeline was implanted. The pipeline delivery wire was removed from the patient post pipeline deployment as per the ifu. After the wire was removed, the physician inspected the wire and noticed a coating on the wire had flaked and stripped off in several locations along the length of the wire. No damage was found on marksman microcatheter. The physician shaped the wire that was used to thet the marksman in. Angiography post procedure was normal. No patient injury was reported as a result of this procedure.

 
Manufacturer Narrative

The device will not be returned for evaluation as it was kept by the user facility. Per the customer's photos, the ptfe coating appeared to be damaged at several locations along the pushwire. No other anomalies were observed. No other complaints have been reported against the lot number. The lot history record review of the reported lot number showed no discrepancies that may have contributed to the reported experience. Based on the customer's photo, the customer's report was confirmed. The ptfe coating was damaged. However, the cause for damage could not be determined. All products are 100% inspected for damage and irregularities during manufacture.

 
Manufacturer Narrative

Received additional information from user facility medwatch. The pipeline was used in an unapproved anatomical location (posterior communicating artery - pcom). Per pipeline flex instruction for use: the pipeline¿ embolization device (ped) is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments.

 
Event Description

Additional information from medwatch: female with left-sided pcom aneurysm underwent pipeline embolization. Inspection of the pusher wire after the procedure demonstrated multiple areas of chipping of the hydrophilic coating. After the procedure, the patient was awakened and found to have no new neurologic deficits. She tolerated the procedure well and left the interventional suite in stable condition. A few weeks later the patient was transferred from another hospital with stroke like symptoms. Lesions seen on mri are suspected as being related to chipped hydrophilic material. Patient has been discharged and is currently clinically stable.

 
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Brand NamePIPELINE EMBOLIZATIN 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
9498373700
MDR Report Key4726781
MDR Text Key20151238
Report Number2029214-2015-00423
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User facility,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/24/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/04/2016
Device MODEL NumberFA-77475-18
Device LOT Number9824980
OTHER Device ID Number008364620146641611049824980
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 Received07/15/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/05/2013
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: 04/24/2015 Patient Sequence Number: 1
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