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

Model Number UNK-NV-MARKSMAN

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Cognitive Changes (2551); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

G2: citation: authors: lu j, zhao y, zhang h, li t, song d, sheng g, maimaitili, wang y, feng w, wang y, wan j, mao g, shi h, yang x, liu j, zhao y.Learning curve in pipeline embolization device: results from the pipeline embolization device in china post-market multi-center registry study.International journal of surgery 109(8):2159-2167 2023.10.1097/js9.0000000000000467 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 is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature was reviewed regarding the learning curve in pipeline embolization devices.This study aimed to investigate the impact of operator experience on complication and poor outcome rates, as well as the learning curve for ped.A total of 217 patients were consecutively enrolled from four eligible centers and divided into three groups based on the number of procedures performed: group 1 (first ten procedures), group 2 (11-20 procedures), and group 3(>20 procedures).The study found that major complications and poor outcomes occurred in 5.1% and 2.3% of cases, respectively.The rate of major complications decreased from 10.0% in group 1 to 2.9% in group 3 (p = 0.053), while the rate of poor outcomes decreased from 7.5% in group 1 to 0.7% in group 3 (p = 0.015).  adjunctive coils were used in 62.7% (136/217) of patients, and balloon angioplasty was required in 6.9% (15/217) of cases due to insufficient ped expansion.11 patients (5.1%, 11/217) experienced complications, which included distal intraparenchymal hemorrhage (n=1), subarachnoid hemorrhage (n=5), ischemic strokes (n=3), transient ischemic attack (n=1), and mass effect deterioration (n=1).One patient simultaneously suffered a subarachnoid hemorrhage and ischemic stroke.Two patients (1.0%, 2/217) experienced procedure-related vascular dissection and one patient (0.5%, 1/217) experienced intraoperative thrombosis.Five (2.3%, 5/217) patients had poor neurological functional outcomes at discharge.

• 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: 18430586
• MDR Text Key: 331859176
• Report Number: 2029214-2024-00007
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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
• Date Manufacturer Received: 12/05/2023
• 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 H10...
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female