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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-25
Device Problem Activation Failure (3270)
Patient Problems Fistula (1862); Neurological Deficit/Dysfunction (1982)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as it was successfully implanted on the patient.The events reported occurred post the embolization procedure and its exact cause remains unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Based on the reported information, there was no reasonably suggestion that a quality deficiency of the device occurred during the post the procedure.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure and patient conditional related event.Possible contributing factor of "failure to open" include patient's vessel tortuosity.Per our ifu: "begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Re-sheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.Carefully inspect the deployed pipeline flex embolization device under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ if information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report through literature review of ¿transvenous coil embolization for the treatment of carotid cavernous fistula after pipeline placement: a case report¿ (ryuta nakae, masaya nagaishi, issei takano, yoshihiro tanaka, akio hyodo, and kensuke suzuki).During the procedure and after device deployment, the delivery microcatheter was exchanged for a balloon to conduct angioplasty to expand the ped and fix the stent along the arterial wall.The postoperative course was uneventful, and the patient was discharged 8 days post procedure with no evidence new neurologic symptoms.On post-procedure day 9, the patient complained of a headache.On post-procedure day 10, her left oculomotor nerve palsy had worsened, and she had developed left abducens nerve palsy, left exophthalmos, and left chemosis.Brain computed tomography scans showed no evidence of subarachnoid hemorrhage.Angiography revealed a left direct carotid cavernous fistula (ccf) resulting from rupture of the aneurysm that had been treated with ped, along with venous reflux into the superior ophthalmic vein and superficial middle cerebral vein.The ccf was treated with transvenous coil embolization.Post the coil embolization, the control angiography showed significant flow reduction in the ccf, as indicated by the significant contrast stagnation within the aneurysm, and complete resolution of the venous reflux into the superior ophthalmic and superficial middle cerebral veins.Angiography post this procedure showed complete resolution of the ccf and significant thrombus formation within the aneurysm sac.The patient was also treated with corticosteroids; her left exophthalmos and chemosis were resolved the day after the procedure.She was discharged 29 days after the second procedure with minor resolution of her left oculomotor and abducens nerve palsies.Left oculomotor nerve palsy was partially resolved, and left abducens nerve palsy was completely resolved by 3 months post procedure.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL 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
9492753836
MDR Report Key7447058
MDR Text Key106070912
Report Number2029214-2018-00304
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPED-475-25
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/26/2018
Initial Date FDA Received04/20/2018
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 Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age81 YR
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