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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2017
Event Type  Injury  
Manufacturer Narrative
Citation: pipeline embolization device for recurrence of previously treated aneurysms. David dornbos iii, md, constantine l. Karras, ba, et. Al. Doi: 10. 3171/2017. 3. Focus1744. This study was designed to assess the safety and efficacy of ped in the recurrence of previously treated aneurysms. The authors reviewed a total of 13 cases in which patients underwent secondary placement of a ped for aneurysm recurrence following prior treatment with another modality. The peds were used to treat aneurysm recurrence or residual following endovascular coiling in 7 cases, flow diversion in 2, and microsurgical clipping in 4. The mean time between initial treatment and retreatment with a ped was 28. 1 months, 12 months, and 88. 7 months, respectively. The devices will not be returned for evaluation as they remain implanted; therefore, no evaluation can be performed. There is no evidence suggesting that the device was defective, but rather an event related to the patient's condition. Additional information has been requested from the author of this article regarding this case. Should it become available a supplemental report will be submitted. Related mdrs for this article: 2029214-2017-00950. 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 through literature review that approximately 17 months after treatment with the pipeline device, the patient was re-treated with another pipeline device due to reoccurrence or residual aneurysm. The patient originally presented with a fusiform, unruptured dissecting pseudoaneurysm measuring 15. 4 mm in the right petrous internal carotid artery (ica) which was treated with pipeline. It was reported that patient demonstrated a substantial decrease in aneurysm size following the initial ped procedure. The residual aneurysm was predominantly located at the proximal and distal regions of prior treatment, and given the marked improvement following initial ped placement, an additional ped placement was pursued. The patient experienced complete aneurysm occlusion, with an mrs score of 0 and follow-up of 13 months.
 
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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
9498373700
MDR Report Key6777740
MDR Text Key82170826
Report Number2029214-2017-00951
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberNO INFORMATION
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 Received07/25/2017
Was Device Evaluated by Manufacturer? No
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: 08/09/2017 Patient Sequence Number: 1
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