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U.S. Department of Health and Human Services

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

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COVIDIEN (RVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 06/01/2017
Event Type  Injury  
Manufacturer Narrative
Ryan, r. W. , khan, a. S. , barco, r. , <(>&<)> choulakian, a. (2017). Pipeline flow diversion of ruptured blister aneurysms of the sup raclinoid carotid artery using a single-device strategy. Neurosurgical focus, 42(6). Doi:10. 3171/2017. 3. Focus1757 the pipeline flex device performed as intended, as indicated by successful implantation in the treatment of a right ica aneurysm. There were no reports of device issues during implantation. The pipeline flex will not be returned for evaluation as it remains implanted in the patient. Product analysis cannot be performed. The information provided is not enough to determine a causal relationship between aneurysm growth and pipeline flex implantation. Based on the reported information, there is no evidence suggesting that the device was defective; this event is more likely to be patient-condition event. Mdrs related to this article: 2029214-2017-00851, 2029214-2017-00852, 2029214-2017-00853. 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 literature review found reports of retreatment after pipeline flex implantation. The purpose of this article was to describe the experience with the use of pipeline flow diversion for treatment of ruptured blister aneurysms. The authors identified 13 patients who presented with subarachnoid hemorrhage from ruptured blister aneurysm(s). All patients were treated with pipeline flow diversion. Of the patients, 11 were women and 2 were men. Blister aneurysms were defined as small lesions occurring on the sidewall of the internal carotid artery (ica) at nonbranching sites and having a dome width equal to or great than its height. In case 8, the patient underwent retreatment three months after pipeline flex implantation. The patient had presented with sudden onset of severe headache (hunt and hess grade ii), and a head ct demonstrated diffuse sah (fisher grade 2). The patient underwent diagnostic cerebral angiography, which demonstrated a 3mmx1mm dorsal right ica blister aneurysm, along with a 2. 5mmx1mm right posterior communicating artery infundibulum and a 2mmx1mm left posterior communicating artery infundibulum. The ruptured lesion was thought to be the dorsal right ica blister aneurysm given its size and shape. Following angiography the patient was noted to have 3/5 right upper-extremity weakness, and an mri view of the brain showed a small area of acute infarction in the left supplementary motor cortex. Two days later, the patient underwent uncomplicated embolization of the dorsal right ica blister aneurysm with the pipeline flex embolization device. The patient was eventually discharged home in good condition, with improvement in her right upper-extremity weakness to only minimal weakness of her right hand. Three months later, the patient underwent follow-up cerebral angiography, which showed that the treated aneurysm had grown to 4. 5mmx2mm, and a second pipeline flex was placed at that time.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (RVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (RVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key6688121
MDR Text Key79120237
Report Number2029214-2017-00852
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 06/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/05/2017 Patient Sequence Number: 1
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