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

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

Patient Problems Infarction, Cerebral (1771); Death (1802); Intracranial Hemorrhage (1891); Ischemia (1942); Occlusion (1984); Stenosis (2263); Vascular Dissection (3160)

Event Type  Death  

Manufacturer Narrative

The device was not returned for analysis and the device was implanted.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.The reported adverse events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following report through literature review of ¿flow diverter therapy using a pipeline embolization device for 100 unruptured large and giant internal carotid artery aneurysms in a single center in a japanese population¿ (hidenori oishi, kosuke teranishi, kenji yatomi, takashi fujii, munetaka yamamoto, and hajime arai) the patients¿ mean age was 63.4 years (range, 19¿88) at the initial treatment and 90 patients (89.4%) were women.Significant in-stent stenosis without neurological symptoms occurred in one patient who underwent percutaneous balloon (hyperform or transform (stryker) angioplasty to resolve the stenosis.However, a direct carotid cavernous fistula (dccf) developed because of the vessel dissection during balloon inflation.The patient underwent internal coil trapping of the dissected parent artery without clinical modification.Spontaneous parent artery occlusion (pao) occurred in three patients during the follow-up period: asymptomatic (2) and symptomatic (1).Eight patients did not undergo a scheduled follow-up catheter angiography due to: the short follow-up duration (5), a delayed aneurysm rupture (2), and an unsuitable systemic condition for catheter angiography (1).Symptomatic ischemic complications occurred in two patients.One patient suffered from very delayed (>2 years after the procedure) device occlusion with a major ischemic stroke associated with discontinuation of antiplatelet therapy.This case was reported in the literature.Another patient suffered a minor stroke immediately following the procedure.Diffusion weighted-imaging on the day of the procedure showed multiple high-intensity signals (hiss) in the treated cerebral hemisphere because of distal embolisms and/or parent artery flow insufficient during the ped deployment.Fortunately, the patient¿s symptoms were transient, and the patient fully recovered within 30 days after the procedure.Ninety-three patients underwent a diffusion-weighted imaging study within 3 days after the procedure.Among those, 83 patients showed new hiss suggesting microembolic lesions.Hemorrhagic events occurred in four patients: dccf due to rupture of a treated aneurysm (2) and remote intraparenchymal hemorrhage (2).Two patients suffering from delayed aneurysm rupture developed a dccf, one on day 4 and the other 2 weeks after the procedure.Those patients under¬went transvenous coil embolization successfully with preservation of the ica.The first patient among those was reported in the literature.Two patients suffered from remote intraparenchymal hemorrhage, one patient developed a large ipsilateral frontal lobe hematoma on the day after the procedure.One of the causes was thought to be excessive platelet inhibition because of the patient¿s four reaction units for clopidogrel and 584 for aspirin at the onset.Although the patient suffered from hemiplegia and dysphasia, there was steady but gradual improvement during a 3-month stay in the hospital.The patient was transferred to the rehabilitation center being able to walk without a cane.The other patient developed a small, asymptomatic intraparenchymal hematoma in the temporal lobe of the ped deployed side 4 days after the procedure.Although the patient¿s platelet inhibition was at an acceptable level with the 397 reaction units for clopidogrel and 155 for aspirin just before the procedure, the load of clopidogrel decreased from 50 to 25 mg.The 6-month follow-up angiography showed the pao without any neurological deficits.Morbidity and mortality were defined as a deterioration of the mrs score to > 0 at 30 days after the procedure.Four patients had a deteriorated mrs score and one patient, an (b)(6) woman with a symptomatic giant carotid cavernous aneurysm, died 32 days after the procedure because of a complication unrelated to the procedure or the device, mainly pneumonia leading to systemic organic failure.Therefore, the morbidity and mortality rates were 4.3% and 1.1%, per patient and 4% and 1%, per aneurysm, respectively.Regarding the outcomes of cranial nerve dysfunction due to the aneurysm¿s mass effect: 18 of 40 (45%) symptomatic aneurysms showed some improvement or complete resolution, 19 (47.5%) were unchanged, and 3 (7.5%) were deteriorations during the follow-up period (mean, 13.5 months, range, 1¿45 months).In detail: the optic nerve showed improvement (3), unchanged (5), worsening (2); the oculomotor nerve improvement (7), unchanged (9); the abducens nerve improvement (8), unchanged (3), worsening (1); and the trigeminal nerve unchanged (2).Motor nerve dysfunction tended to improve after ped embolization; however, the sensory nerve dysfunction did not improve.No patients exhibited de novo cranial nerve dysfunction after the ped embolization of asymptomatic aneurysms.Navien, marksman and hyperform were the reported ancillary devices.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8771389
• MDR Text Key: 150530772
• Report Number: 2029214-2019-00695
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• 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): Death