MARKSMAN

Report

Report Number: 2029214-2023-01679
Event Type: Injury
Date Received: September 12, 2023
Date of Event: May 24, 2023
Report Date: September 12, 2023
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3
Product Code: KRA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

SEE ATTACHMENTS FOR LITERATURE ARTICLE. EVENT RELATED TO REGULATORY. REPORT: 2029214-2023-01677 AND 2029214-2023-01678. 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.

Description of Event or Problem · 0

ZHANG Y., ZHANG F., TURHON M., HUANG J., LI M., PENG Q., ZHENG Z., LIU J., ZHANG Y., LIU J., ZHANG H., LI T., SONG D., ZHAO Y., AISHA M., WANG Y., FENG W., WANG Y., WAN J., MAO G., SHI H., GUAN S.; CLINICAL NEUROADIOLOGY; 2023; TREATMENT OF INTRACRANIAL VERTEBRAL ARTERY DISSECTING ANEURYSMS USING PIPELINE EMBOLIZATION DEVICES; DOI: 10.1007/S00062-023-01318-7 MEDTRONIC RECEIVED INFORMATION THAT PATIENTS TREATED WITH PED PIPELINE STENTS AND MARKMAN CATHETERS HAD COMPLICATIONS. THE PURPOSE OF THE STUDY WAS TO PROVIDE A RELIABLE AND COMPREHENSIVE ANALYSIS OF THE EFFECTIVENESS AND SAFETY OF PED IN THE TREATMENT OF INTRACRANIAL VERTEBRAL ARTERY DISSECTING ANEURYSM (IVADA). THEY RETROSPECTIVELY REVIEWED THE PLUS DATABASE TO IDENTIFY PATIENTS WHO HAD IVADAS AND WERE TREATED WITH PEDS FROM 2014 TO 2019 AT 14 CENTERS ACROSS CHINA. IN THIS STUDY 52 CONSECUTIVE PATIENTS WITH 52 IVADAS WERE INCLUDED. THE MEAN AGE WAS 52.33 YEARS AND 82.7% WERE MALE. ALL IVADAS WERE UNRUPTURED PRIOR TO THE PROCEDURE EXCEPT FOR ONE WITH A PREVIOUS SUBARACHNOID HEMORRHAGE (SAH). MOST PATIENTS (48/52, 92.3%) PRESENTED WITH GOOD NEUROLOGICAL FUNCTIONAL STATUS (MRS SCORE 0¿1) BEFORE TREATMENT. THE IMAGING DIAGNOSTIC CRITERIA FOR IVADAS WERE FUSIFORM OR IRREGULAR ANEURYSMAL DILATION AT THE VERTEBRAL ARTERY WITH AT LEAST ONE OF THE FOLLOWING PRESENTATIONS: (1) INTRAMURAL HEMATOMA, INTIMAL FLAP, OR DOUBLE LUMEN, (2) RAPID MORPHOLOGICAL CHANGES UPON REPEATED IMAGING AND (3) THE PEARL AND STRING SIGN. THE EXCLUSION CRITERIA WERE AS FOLLOWS: (1) NO PED TREATMENT, (2) EXTRACRANIAL VERTEBRAL DISSECTING ANEURYSMS OR BASILAR ARTERY ANEURYSMS AND (3) A HISTORY OF SURGICAL OR ENDOVASCULAR TREATMENT FOR IVADAS. PROCEDURE: PEDS WERE IMPLANTED USING MARKSMAN MICROCATHETERS BY NEURORADIOLOGISTS AT EACH CENTER. THE TYPES OF PEDS USED IN OUR STUDY WERE THE PIPELINE CLASSIC OR PIPELINE FLEX PED. ADDITIONALLY, NEURORADIOLOGISTS DECIDED ON THE USE OF PLUS COILS, OVERLAPPING PEDS, OR BALLOON ANGIOPLASTY DURING THE PROCEDURE. PATIENTS TOOK CONCOMITANT ANTIPLATELET MEDICATION FOR 3 DAYS BEFORE AND 6 MONTHS AFTER TREATMENT. OF THE PATIENTS 84.6% (44/52) WERE TREATED WITH PED IMPLANTATION ALONE, AND 15.4% (8/52) WERE TREATED WITH PED PLUS COILING. THE MEAN WIDTH AND LENGTH OF THE PEDS WERE 3.98 ± 0.61MM AND 29.69 ± 4.72MM, RESPECTIVELY, 5 (9.6%) PATIENTS WERE TREATED WITH MORE THAN ONE PED, 96.2% (50/52) PATIENTS HAD SUCCESSFUL PED DEPLOYMENT AT 1 TIME, WHILE 3.8% (2/52) REQUIRED STENT ADJUSTMENT AFTER THE INITIAL DEPLOYMENT. OUTCOMES: ANGIOGRAPHIC OUTCOMES INCLUDING ANEURYSM OCCLUSION DEGREE, PATENCY OF THE COVERED POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA), AND IN-STENT STENOSIS (PARENT VESSEL NARROWING > 25%) WERE RECORDED. AFTER PED DEPLOYMENT, 78.8% (41/52) PATIENTS HAD PICA OSTIAL COVERAGE AND 9.6% (5/52) IVADAS ACHIEVED IMMEDIATE ANEURYSM OCCLUSION. AFTER A MEAN FOLLOW-UP OF 10.5 MONTHS (RANGING FROM 3 TO 36 MONTHS), 93.8% (45/48) IVADAS ACHIEVED COMPLETE OCCLUSION. NO RECURRENCE OR IN-STENT STENOSIS WAS FOUND: THE COVERED PICA WAS PATENT IN 58.5% (24/41) OF PATIENTS, HAD DIMINISHED FLOW IN 39.0% (16/41) OF PATIENTS, AND WAS OCCLUDED IN 2.4% (1/41) OF PATIENTS. AT THE LAST FOLLOW-UP, 94.2% (49/52) OF PATIENTS HAD FAVORABLE FUNCTIONAL OUTCOMES (MRS SCORE 0¿1). ONLY 3.8% (2/52) PATIENTS HAD PERSISTENT POOR CLINICAL OUTCOMES (MRS SCORE 2¿5). THE MORBIDITY AND MORTALITY RATES WERE 11.5% (6/52) AND 1.9% (1/52), RESPECTIVELY. THE ONLY SAH PATIENT SUFFERED NO COMPLICATIONS FROM THE TREATMENT WITH PED ALONE AND ACHIEVED COMPLETE OCCLUSION OF THE IVADA AT THE 6-MONTH FOLLOW-UP. SIX PATIENTS HAD COMPLICATIONS. ALL HAD SUCCESSFUL DEVICE DEPLOYMENT. OF THE PATIENTS FIVE (5/52, 9.6%) EXPERIENCED PERIOPERATIVE COMPLICATIONS AFTER THE PROCEDURE: TWO PATIENTS SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA) ON THE FIRST OR SECOND DAY, BUT THE SYMPTOMS WERE COMPLETELY RELIEVED AFTER DRUG THERAPY; ONE PATIENT SUFFERED ISCHEMIC STROKE, PICA OCCLUSION AND COMA ON THE THIRD DAY, WHILE THE OTHER PATIENT DEVELOPED DISTAL INTRAPARENCHYMAL HEMORRHAGE (DIPH) ON THE SECOND DAY AND IMMEDIATELY UNDERWENT INTRACRANIAL HEMATOMA EVACUATION, THEY HAD A DISCHARGE MRS SCORE OF 5; ONLY ONE PATIENT DIED DUE TO DELAYED ANEURYSMAL RUPTURE ON THE SIXTH DAY. DURING THE EARLY POST-OPERATIVE PERIOD, THE 4 PATIENTS¿ CLINICAL OUTCOMES REMAINED RELATIVELY UNCHANGED FROM WHEN THEY WERE DISCHARGED. THE RATE OF EARLY POSTOPERATIVE COMPLICATIONS WAS 9.6%. DURING FOLLOW-UP, THE CLINICAL OUTCOMES OF THE FOUR AFOREMENTIONED SURVIVORS DID NOT IMPROVE. FOR THE OTHER PATIENTS WITHOUT EARLY POSTOPERATIVE COMPLICATIONS, MOST PATIENTS RECOVERED WELL, EXCEPT FOR ONE PATIENT (1/52, 1.9%) WHO SUSTAINED NEW-ONSET PICA FLOW REDUCTION AND DIZZINESS. INTENSIVE ANTIPLATELET DRUGS ASSISTED IN RELIEVING THIS SYMPTOM, AND THIS PATIENT HAD A MRS SCORE OF 1 AFTER 8 MONTHS. THERE WERE NO SIGNIFICANT FACTORS CHARACTERIZING POSTOPERATIVE COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
801848	MARKSMAN	CATHETER, CONTINUOUS FLUSH	KRA	MICRO THERAPEUTICS, INC. DBA EV3	UNK-NV-MARKSMAN	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	52 YR	Male	Required Intervention\| H