MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR REFLEX CATHETER; CATHETER, PERCUTANEOUS

Model Number UNK-NV-RFX

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 07/01/2016

Event Type  Death  

Event Description

Zhang j, yu m, lv x.Endovascular treatment of blood blister-like aneurysms of internal carotid artery: stent-assisted coiling and pipeline flow diversion.Journal of clinical neuroscience, 90 (2021) 8-13.Https://doi.Org/10.1016/j.Jocn.2021.04.040.  medtronic review of the literature article found described retrospective study of 27 patients who underwent endovascular treatment with stent-assisted coiling or pipeline flow diversion to treat subarachnoid hemorrhage (sah) due to rupture of internal carotid artery blood blister-like aneurysms from july 2016 through july 2020.A proximal stenosis caused by angiopathology adjacent to aneurysms were found on internal carotid artery angiograms in all 27 cases.The angiopathology combining with the aneurysms implement that acute dissection of the supraclinoid segment of the internal carotid artery indicated the pathogenesis of blood blister-like aneurysm formation.  all aneurysms were treated successfully with alleviation of the adjacent angiopathology after stenting on angiograms.During 1 to 12 months (mean 3.5 months) angiographic followup, complete aneurysm obliteration without adjacent stenosis were found in 25(92.6%) patients.The enterprise stent patient experienced postoperative rebleeding at one week hospital day and the aneurysm was retreated with coils.One lvis patient showed aneurysm recanalization at 3 months follow-up and retreated with coils and another lvis stent.The recurrent rate was 7.4%(2/27) in our patients.There was no recurrent bbla in flow diversion patients.During 1¿12 months (mean 3.5 months) clinical follow-up, favorable clinical mrs 0 and 1 was observed in 23(85.2%) patients, mrs 2 in 3(11.1%) patients and 1(3.7%) death caused by coexisting giant brain arteriovenous malformation rupture.One patient presented with non-occult hydrostatic hydrocephalus.No patient developed clinically significant large vessel vasospasm.Continuous cerebrospinal fluid diversion was performed in the 1 patient presenting with hydrostatic hydrocephalus.

Manufacturer Narrative

Related to information reported in regulatory report 2029214-2021-01657.Reported patient age (52 years) is representative of the mean age for all patients included in the study.Reported patient sex (female) is representative of the majority (70.4%) of patients included in the study.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REFLEX CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13063708
• MDR Text Key: 282694117
• Report Number: 2029214-2021-01660
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-RFX
• Device Catalogue Number: UNK-NV-RFX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2021
• 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
• Patient Age: 52 YR
• Patient Sex: Female