MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARKSMAN; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-MARKSMAN

Device Problem No Apparent Adverse Event (3189)

Patient Problems Transient Ischemic Attack (2109); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 06/20/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id nv unk pipeline (unknown); product type: g2: citation: authors: yangyang zhou, huibin kang, wenqiang li, bin luo, chao wang, ruhang xie, yongnan zhu, qichen peng, yisen zhang, jian liu, ying zhang, shiqing mu, sheng guan, wenfeng feng, xinjian yang.Use of tirofban to prevent ischemic events in patients with cyp2c19 loss-of-function alleles during flow diversion of intracranial aneurysm: a multicenter cohort study.Translational stroke research 2023.Doi.Org/10.1007/s12975-023-01171-3 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic literature review found reported of ischemic events in association with pipeline embolization device and marksman catheter.The purpose of this article was to analyze the effect of tirofiban on ischemic events in cyp2c19 loss-of-function (lof) allele carriers during pipeline embolization device (ped) implantation.This study focused on ischemic events within the first postoperative month, including stent thrombosis, ischemic stroke, and transient ischemic attack (tia).  the authors reviewed 278 cases of patients treated for aneurysms using the pipeline embolization device.Of the 278 patients, the average age was 54 years, 192 were female and 86 were male.All 278 patients were divided into 3 groups according to lof allele carrier status and tirofiban use.Group a did not carry the lof allele and received dual antiplatelet treatment, group b carried the lof allele and received dual antiplatelet treatment, and group c carried the lof allele and received dual antiplatelet treatment and tirofiban.The effects of lof alleles on ischemic events were analyzed between groups a and b.The results showed that the lof allele increased ischemic events.The effect of tirofiban on ischemic events was analyzed in the lfacs by comparing groups b and c, and the results showed that dat combined with tirofiban was effective in reducing ischemic events.The article does state balloon angioplasty was used to help correct pipeline stent malposition.There does not state any technical issues during use of the marksman catheter.In addition, this study supports the performance of preoperative cyp2c19 genotyping prior to ped implantation because the lof allele increases the risk of ischemic events.Postoperative prophylactic use of tirofban may help to reduce the risk of ischemic events in lfacs.The following intra- or post-procedural outcomes were noted: ischemic events occurred in 24 patients intraoperative thrombosis in 3 patients post operative transient ischemic attack (tia) in 4 patients ischemic stroke in 17 patients.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 19200785
• MDR Text Key: 341249254
• Report Number: 2029214-2024-00780
• Device Sequence Number: 1
• Product Code: KRA
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARKSMAN
• Device Catalogue Number: UNK-NV-MARKSMAN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2024
• Initial Date FDA Received: 04/29/2024
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Other