MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN NV PRODUCT

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

Patient Problems Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Therapeutic Response, Decreased (2271); Hydrocephalus (3272)

Event Date 04/28/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.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.Hemorrhage, infarctions and neurological deterioration are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure and patient condition related events.Linked with mdr: 2029214-2019-01017.If information is provided in the future, a supplemental report will be issued.

Event Description

Xianyi chen, md, zeyu sun, md, ligen shi, md, liang xu, md, jun yu, md, bing fang, md, jingwei zheng, md, jing xu, md, jianmin zhang, md, phd, http://dx.Doi.Org/10.1097/md.00000000000.Medtronic received the following events through literature review of ¿endovascular management of ruptured distal posterior inferior cerebellar artery aneurysms a retrospective cohort study¿ 36 patients were finally included.28 of them were managed by parent artery occlusion (pao), while 8 patients by selective aneurysm coiling (sac).Compared with sac, patients managed by pao showed lower rate of intraoperative hemorrhage, lower mortality rate (3.57% vs 12.5%) as well as higher complete occlusion rate (100% vs 87.5%).More patients arouse imaging infarction of cerebella in the group of pao than sac (39.29% vs 12.50%) though there was no statistical significance.Procedure related complications reported: 1 intraoperative hemorrhage in the sac.1 operation failure.13 cases of hydrocephalus.13 cerebellar infarction and 2 deaths.Among all 12 (33.33%) patients with new imaging cerebella infarction, none of them showed apparent neurological deficits except 1 patient remain unconscious since the symptom onset.1 patient that managed by pao died after the operation mainly because the serious condition at admission.And 1 patient died because of intraoperative hemorrhage in the group of sac but no statistical significance was found when compared with the group of pao.In addition, 4 of 8 patients with aneurysms located in the tonsillomedullary segment were managed with pao.All these patients showed no neurological deficits after the procedure.Mean time of follow-up was 31 months.The mrs showed no statistical difference in 2 managements (table 3).Most patients (75%) had favorable outcomes at discharge in both groups.1 of 8 patients in the sac group died because of intraoperative hemorrhage.2 patients managed by pao lost of follow-up at 1 year after discharge.No recurrent hemorrhage was found in all patients.Only 1 of 8 patients managed by sac and 8 of 28 patients managed by pao had a digital subtraction angiography (dsa) review and no recurrence were detected.Ancillary devices: axium coil, solitaire ab,onyx liquid embolic.

• Brand Name: UNKNOWN NV PRODUCT
• Type of Device: UNKNOWN NV PRODUCT
• 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 ; 9496801345
• MDR Report Key: 9179000
• MDR Text Key: 168576444
• Report Number: 2029214-2019-01018
• Device Sequence Number: 1
• Product Code: HCG
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• 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: 09/17/2019
• 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): Other