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

Model Number NV UNK PIPELINE

Device Problems Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026); Activation Failure (3270); Migration (4003)

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Unspecified Nervous System Problem (4426)

Event Date 12/08/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Huibin kang, yu zhou, bin luo, nan lv, hongqi zhang, tianxiao li, donglei song, yuanli zhao, sheng guan, aisha maimaitili, yunyan wang, wenfeng feng, yang wang, jieqing wan, guohua mao, huaizhang shi, xinjian yang, and jianmin liu; neurotherapeutics; 2021; 18:1198-1206; pipeline embolization device for intracranial aneurysms in a large chinese cohort: complication risk factor analysis; https:/ /doi.Org/10.1007/s13311-020-00990 medtronic received information in literature of complications in the use if pipeline ped stents in patient treated for intercranial aneurysms  between november 2014 and october 2019 in 14 centers across china. a total of 1171 consecutive patients (mean age, 53.9 ± 11.4; female, 69.6%[813/1171]) with 1322 aneurysms were included in the study.Embolization procedures involved the use of the classic or flex ped.The ped was delivered and deployed through a marksman microcatheter. additional techniques, including the use of adjunctive coils, overlapping peds, and balloon angioplasty, were applied according to the operator¿s preference and experience.The protocol did not specify the coiling methodology, and the decision to use coils with the ped was left to the discretion of the treating physician. patients were administered an antiplatelet regimen that included a combination of aspirin (100¿300 mg daily) and clopidogrel (75 mg daily); however, patients who were identified as clopidogrel non-responders were administered aspirin (100 mg daily) and ticagrelor (90 mg twice daily).The dose of aspirin/clopidogrel was adjusted preoperatively after platelet function testing. the mean aneurysm size, neck size, and parent artery diameter was 12.79 ± 8.75 mm, 6.21 ± 3.92 mm, and 3.88 ± 0.82 mm, respectively. the morphology of aneurysms was saccular in 83.1% (1099/1322), fusiform in 8.2% (109/1322), dissecting in 6.3% (83/1322), and blister in 2.3% (31/1322) of cases.The majority of occlusions were located in the anterior circulation (proximal, 83.6% [1105/1322]; distal, 3.6% [48/1322]), while 12.8% (169/1322) were located in the posterior circulation, including 2.2% (29/1322) in the basilar artery and 10.6% (140/1322) in the vertebral artery and other vessels in the posterior circulation. device deployment to the target site was considered unsuccessful when ped opening failed or when the ped was deployed inside the aneurysm.Successful device deployment to the target site after adjustment was defined when the ped was released successfully after technical adjustments.Device deployment to the target site was considered successful when the ped was released successfully at the target location without technical adjustments.The classic and flex peds were used in similar proportions (45.2% [596/1322] vs.54.8% [723/1322], respectively).The diameter and length of the device was 4.07 ± 0.53 mm and 25.37 ± 5.76 mm, respectively. at the last follow-up for each patient, the total occlusion rate was 81.4% (787/967), 91.6% (1211/1322) of parent arteries were patent, 7.0% (93/1322) of parent arteries were stenotic, and 1.4% (18/1322) of parent arteries were occluded.A total of 93.9% (1241/1322) of peds were successfully deployed to the target site, and the rate of complete occlusion immediately after the operation was 14.6%. the mrs score was 0¿2 and 3¿6 before ped treatment in 1060 (90.5%) and 111 (9.5%) cases, respectively.The mrs score was 0¿2 and 3¿6 in the early postoperative in 1094 93.4%) and 77 (6.6%) cases, respectively.The mrs score was 0¿2 and 3¿6 at follow-up in 1111 (94.9%) and 60 (5.1%) cases, respectively. balloon angioplasty 31 (2.3%). unsuccessful 10 (0.8%).  events were documented at less than 30 days and than again between 3 and 36 months:  major ischemic stroke 44 (3.8%), 7 (0.6%); tia/minor stroke 30 (2.6%), 4 (0.3%); delayed aneurysm rupture (dar) 23 (2.0%), 1 (0.1%)' distal intraparenchymal hemorrhage (diph) 23 (2.0%), 0 (0%); stent migration 9 (0.8%), 0 (0%); access site complications 41 (3.5%).0 (0%); neurological compressive symptoms 44 (3.8%), 7 (0.6%); mortality 15 (1.3%), 2 (0.2%); poor functional outcome, mrs score 3¿6 77 (6.6%), 60 (5.1%).

• Brand Name: PIPELINE
• 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: 13420213
• MDR Text Key: 284856177
• Report Number: 2029214-2022-00135
• Device Sequence Number: 1
• Product Code: OUT
• 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: Other
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2022
• 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): Hospitalization; Death; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female