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

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.

• 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 Key: 7447058
• MDR Text Key: 106070912
• Report Number: 2029214-2018-00304
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• 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 Number: PED-475-25
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2018
• Initial Date FDA Received: 04/20/2018
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR