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

Model Number PED-350-35

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

Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.The reported events 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 post procedure and patient condition related events.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received the following adverse event through literature review of ¿giant vertebrobasilar dissecting aneurysms in pediatric patients¿ (jiejun wang, yisen zhang, ming lv, xinjian yang, zhongbin tian, jian liu, peng liu, zefeng miao, luqiong jia, junfan chen, xinghuan ding, ying zhang, wei zhu, wenqiang li, kun wang and zhongxiao wang) 54 patients agreed to undergo ped therapy.Of these 54 patients, four were 18 years old or younger at the time of presentation (two males, and two females; mean age 9.25 years; age range 8¿11 years).Case 3: an 8¿10-year-old patient with a mrs of 2 experienced a sudden onset of headaches accompanied by dysphagia 2 months before being admitted to our hospital.Cta performed in another hospital revealed a giant dissecting aneurysm located in the vbj, which was confirmed on dsa performed in our hospital.The lva was treated with two peds (3.5 × 35mm), and the rva underwent parent artery occlusion with coils.Immediately postoperative angiography showed excellent reconstruction of the lva, and complete occlusion of the rva.After the procedure, the clinical symptoms were mildly improved compared with preoperatively.One day post-treatment, mri demonstrated a giant mass effect with an intramural hematoma, resulting in severe brainstem compression.Six months post treatment, follow-up dsa revealed complete occlusion of the lva and rva.Compared with mri performed at 1 day post-treatment, follow-up mri showed a marked reduction in the mass effect.At 6 months after the procedure, the patient had no clinical problems and/or focal neurological function deficiency, with a mrs of 0.As this patient had weak dual posterior communicating arteries preoperatively, the good clinical outcome might be attributed to the presence of robust dual posterior communicating arteries after the procedure.

• Brand Name: PIPELINE FLEX
• 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: 8768865
• MDR Text Key: 150409090
• Report Number: 2029214-2019-00691
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PED-350-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2019
• 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): Other