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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-30
Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)
Patient Problems Occlusion (1984); Foreign Body In Patient (2687)
Event Date 08/24/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex device will not be returned for evaluation as it was implanted in the patient. The device was not returned, therefore the reported event could not be confirmed and an event cause could not be determined from the reported information. Mdrs related to this event: 2029214-2016-00816, 2029214-2016-00817.
 
Event Description
Medtronic received report that a pipeline flex did not open during a procedure. The patient was undergoing treatment for an unruptured, fusiform aneurysm in the left cavernous internal carotid artery (ica). The vessel was moderately tortuous. The aneurysm max. Diameter was 25mm and neck diameter was 7mm. Landing zone artery size was 3. 8mm distal and 4. 1mm proximal. The devices were prepared as indicated in the ifu. It was reported that during attempt of a pipeline flex, the device was deployed across the aneurysm neck. The physician felt that the device could be more open in the middle section; a j-wire was used to "bump" against the pipeline. While doing this, the proximal end of the pipeline "flew up" and landed in the aneurysm; the distal section of the pipeline remained in the cavernous ica. The physician lost wire access to the pipeline. The physician attempted several retrieval devices, without success. The procedure was ended. The next day, the physician performed a balloon occlusion test and decided to implant a microvascular plug for a vessel sacrifice. There were no reports of patient symptoms.
 
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Brand NamePIPELINE FLEX 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 Key5957579
MDR Text Key106748680
Report Number2029214-2016-00817
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,Followup,Followup
Report Date 08/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/13/2018
Device Model NumberPED-400-30
Device Lot NumberA106519
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 Received11/14/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/14/2015
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: 09/16/2016 Patient Sequence Number: 1
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