MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number NV UNK FLEX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Granuloma (1876); Headache (1880); Nausea (1970); Blurred Vision (2137)

Event Date 03/15/2021

Event Type  Injury  

Event Description

Boyle, t., fernando, s.L., steinfort, b., li, j., krause, m., harrington, t., assaad, n., <(>&<)> faulder, k.(2021).Medical treat ment of polymeric cerebral granulomatous reactions following endovascular procedures.Journal of neurointerventional surgery, 13(11), 1032¿1036.Https://doi.Org/10.1136/neurintsurg-2020-016806.Medtronic review of the literature article found that the authors reviewed three cases of cerebral granulomatous reactions that occurred after endovascular intervention for internal carotid aneurysms.These three cases represent the largest biopsy proven series of cerebral granulomatosis following endovascular intervention.Two of the three cases had unusually delayed onset of up to 4 years following the intervention.Two patients of the three cases had medtronic devices implanted.Patient 1 - the patient was a middle-aged female who had previously had two pipeline flex stents implanted to treat a right internal carotid artery (ica) aneurysm with microvascular ischemia.There were no reported intra-operative issues or device malfunctions noted.About 4 years later, the patient developed recurrent headaches, blurred vision, and nausea.Mri imaging revealed multiple enhancing lesions.Positron emission tomography¿computed tomography (pet-ct) and microbiology (including gram, india ink, and ziehl¿neelsen stains and cryptococcal antigen) on csf did not yield alternate diagnoses.Csf protein was elevated to 0.59 g/l in the absence of pleocytosis with matching serum and csf oligoclonal bands.Extensive infective and autoimmune serology testing (antinuclear antibodies, extractable nuclear antigen antibodies, chromatin antibodies, antineutrophil cytoplasmic antibodies, rheumatoid factor, anticyclic citrullinated antibodies) was unremarkable, and angiotensin converting enzyme level as well as lymphocyte surface markers were normal.A brain biopsy performed showed a chronic suppurative granulomatous reaction surrounding slender curvilinear fragments of non-polarizable material with no bacterial, mycobacterial, or fungal disease.The patient responded to a combination of prednisone (commenced at 1 mg/kg daily and tapered over 4 months due to metabolic disease) and mycophenolate mofetil 1.5 g twice daily.Steroid therapy caused adverse effects, including insomnia and weight gain.Follow-up mri at 1 year showed ongoing nodular enhancement within the right posterocentral sulcus at the location of one of the previously resected lesions.The patient continues to be monitored after 2 years of immunosuppression and experiences mild intermittent headaches with no impact on her daily function.Ancillary devices: navien 5f intracranial support catheter, marksman microcatheter patient 2 did not have a medtronic device implanted.Patient 3 - the patient was a 30-40 year old female with a left ica aneurysm detected on investigation of dizziness while residing in china.The patient had several non-medtronic coils and stent implanted.Three years later, the patient presented with headache.Mri showed numerous intra- and extra-axial enhancing lesions, several with associated vasogenic edema.Angiography revealed filling of the aneurysmal sac leading to a further coiling procedure.A co-axial guide was utilized but there was difficulty maneuvering this due to the existing stent.Five axium prime coils were inserted into the aneurysmal sac during a 2.5 hour procedure.The patient had persistent headaches post-operatively and subsequent mri revealed some resolution of old lesions with new enhancing lesions in the vascular territory of the treated aneurysm.A parietal lesion was biopsied and revealed necrotizing granulomatous inflammation in the presence of non-refractile, non-polarizable, curvilinear fragments, and absence of mycobacterial and fungal disease.Blood tests showed a negative infective screen and autoimmune serology, including antinuclear antibodies, antineutrophil cytoplasmic antibodies, and angiotensin converting enzyme level was unremarkable.Treatment with a tapering course of prednisone commencing at 1 mg/kg for a total of 16 months without significant adverse effects, combined with methotrexate up to 20 mg weekly, resulted in resolution or reduction of previously detected lesions and abrogation of symptoms.Although new lesions were recently detected in the left occipitotemporal junction after a total of 27 months of immunosuppression, the patient continues to function normally in her occupation.Consideration will be given to increasing the dose of methotrexate or switching to mycophenolate mofetil.Ancillary device used in initial procedure: echelon 14 catheter.

Manufacturer Narrative

A separate report will be submitted regarding patient 3 in the article who was treated with axium coils.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13612679
• MDR Text Key: 289201837
• Report Number: 2029214-2022-00313
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK FLEX
• Device Catalogue Number: NV UNK FLEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• 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; Other
• Patient Sex: Female