PIPELINE

Report

Report Number: 2029214-2023-00215
Event Type: Death
Date Received: February 8, 2023
Date of Event: February 18, 2022
Report Date: February 8, 2023
Manufacturer: MICRO THERAPEUTICS, INC. DBA EV3
Product Code: OUT
PMA / PMN Number: P100018
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

WU Q, XU S, WANG C, ET AL. ENDOVASCULAR MANAGEMENT OF VERTEBROBASILAR TRUNK ARTERY LARGE ANEURYSMS: COMPLICATIONS AND LONG-TERM RESULTS. FRONTIERS IN NEUROLOGY. 2022;13:839219. DOI:10.3389/FNEUR.2022.839219. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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

WU Q, XU S, WANG C, ET AL. ENDOVASCULAR MANAGEMENT OF VERTEBROBASILAR TRUNK ARTERY LARGE ANEURYSMS: COMPLICATIONS AND LONG-TERM RESULTS. FRONTIERS IN NEUROLOGY. 2022;13:839219. DOI:10.3389/FNEUR.2022.839219. MEDTRONIC LITERATURE REVIEW FOUND A REPORT OF PATIENT COMPLICATIONS IN ASSOCIATION WITH THE SOLITAIRE STENT, PIPELINE STENT, AND ONYX. THE PURPOSE OF THIS ARTICLE WAS TO ANALYZE THE COMPLICATIONS AND LONG-TERM RESULTS OF ENDOVASCULAR MANAGEMENT OF VERTEBROBASILAR TRUNK LARGE (=10 MM) ANEURYSMS (VBTLAS) AND IDENTIFY PREDICTORS OF OUTCOMES. BETWEEN JANUARY 2014 AND DECEMBER 2020, 6,987 PATIENTS WITH INTRACRANIAL ANEURYSMS WERE REFERRED TO THE AUTHORS' CENTER FOR ANEURYSM MANAGEMENT AND 2,224 PATIENTS HAVE UNDERGONE THE ENDOVASCULAR PROCEDURES. THE AUTHORS RETROSPECTIVELY REVIEWED THE DATABASE AND IDENTIFY ALL THE PATIENTS WITH VBTLAS. A TOTAL OF 62 VBTLAS WERE IDENTIFIED. AMONG THEM, 24 ANEURYSMS WERE TREATED WITH OVERLAPPING STENT TECHNIQUES, 18 ANEURYSMS WERE TREATED WITH FLOW DIVERSION, 14 ANEURYSMS WERE TREATED WITH SINGLE STENT-ASSISTED COILING, AND 6 ANEURYSMS WERE TREATED WITH COILING ALONE. TEN PATIENTS WERE TREATED WITH PARENT ARTERY OCCLUSION OR UNILATERAL VERTEBRAL ARTERY OCCLUSION. THE ARTICLE DOES NOT STATE ANY TECHNICAL ISSUES DURING USE OF THE SOLITAIRE, PIPELINE, AND ONYX. THE FOLLOWING INTRA- OR POST-PROCEDURAL OUTCOMES WERE NOTED: -THE OVERALL COMPLICATION RATE WAS 10/62, INCLUDING NINE ISCHEMIC EVENTS AND ONE HEMORRHAGIC EVENT; 7 PATIENTS OCCURRED DURING THE PERIPROCEDURAL PHASE AND 3 PATIENTS OCCURRED DURING THE FOLLOW-UP. - TWO PATIENTS TREATED WITH FD EXPERIENCED THE IN-STENT THROMBOSIS, OF WHICH ONE OCCURRED INTRAPROCEDURALLY AND THE OTHER OCCURRED DURING THE FOLLOW-UP. -AMONG THE SEVEN PERIPROCEDURAL COMPLICATIONS, ONE PATIENT WAS TREATED FOR A VERTEBRAL ANEURYSM BY USING FD DEVELOPED ACUTE PARENT ARTERY OCCLUSION DURING THE IMMEDIATE POST-PROCEDURAL DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND CATHETER-DIRECTED THROMBOLYSIS WITH UROKINASE WAS THEN PERFORMED. THE PATIENT PRESENTED NO NEUROLOGICAL DEFICIT AFTER DISCHARGE, BUT THE PATIENT DIED DUE TO THE ACUTE CEREBRAL INFARCTION DURING THE FOLLOW-UP. -A TOTAL OF 3 PATIENTS EXPERIENCED NEW-ONSET NEUROLOGICAL DEFICITS DURING THE FOLLOW-UP. ONE PATIENT TREATED FOR A BASILAR ARTERY ANEURYSM EXPERIENCED IN-STENT THROMBOSIS 5 MONTHS AFTER THE FD IMPLANTATION. DESPITE THE ASPIRATION THROMBECTOMY WAS PERFORMED, THE PATIENT DIED 1 DAY LATER. A PIPELINE EMBOLIZATION DEVICE WAS DEPLOYED WITHOUT ADJUNCTIVE COILING. THE IMMEDIATE POSTPROCEDURAL VASO CT SHOWED THAT THE STENT WAS DEPLOYED PROPERLY. THE POSTPROCEDURAL DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) SHOWED THE PATENCY OF THE PARENT ARTERY AND THE BLOOD FLOW DETAINED TO THE VENOUS PHASE WAS DETECTED. THE PATIENT PRESENTED SUDDEN NAUSEA, VOMITING, AND PROGRESSIVE CONSCIOUSNESS DISORDER 5 MONTHS AFTER THE PROCEDURE. EMERGENCY DSA SHOWED THAT THE PARENT ARTERY WAS OCCLUDED AND ASPIRATION THROMBECTOMY WAS PERFORMED. BLOOD FLOWWAS RESTORED AFTER THE PROCEDURE AND THE ANEURYSM NECK RESIDUAL WAS DETECTED. THE PATIENT DIED 1 DAY LATER. -THE TWO PATIENTS THAT EXPERIENCED DYSPHAGIA AFTER THE SINGLE-STENT ASSISTED COILING AND OVERLAPPING STENT-ASSISTED COILING OF THE VERTEBRAL ANEURYSM AND VERTEBROBASILAR JUNCTION ANEURYSM, RESPECTIVELY. THE MRS SCORE AT DISCHARGE WAS BOTH 1. HOWEVER, THE TWO PATIENTS DIED DURING THE FOLLOW-UP, ONE OF THEM DIED DUE TO THE PULMONARY EMBOLISM AFTER ACUTE CEREBRAL INFARCTION, AND THE OTHER PATIENT DIED DUE TO THE COMPLICATIONS AFTER ACUTE CEREBRAL INFARCTION. -ONE PATIENT TREATED FOR A BASILAR ANEURYSM WITH OVERLAPPING STENT TECHNIQUES PRESENTED DYSPHAGIA AND TWO-SIDED MOTOR WEAKNESS AND F OLLOWING BRAIN MRI DEMONSTRATED THE ACUTE CEREBELLAR INFARCTIONS: THE MRS SCORE AT DISCHARGE WAS 4. ONE PATIENT PRESENTED PERSISTENT DIZZINESS 5 DAYS AFTER THE OVERLAPPING STENT-ASSISTED COILING OF A BASILAR ANEURYSM AND ACUTE CEREBELLAR INFARCTIONS WERE ALSO NOTED IN BRAIN MRI: THE MRS SCORE AT DISCHARGE WAS 1. -ONE PATIENT PRESENTED ONE-SIDED MOTOR WEAKNESS AFTER THE OVERLAPPING STENT-ASSISTED COILING OF A BASILAR ANEURYSM AND THE MRS SCORE AT DISCHARGE WAS 4. -THE OTHER ONE PATIENT TREATED FOR A VERTEBROBASILAR JUNCTION ANEURYSM WITH SINGLE STENT-ASSISTED COILING DEVELOPED A HEADACHE 3 DAYS AFTER THE PROCEDURE AND A CT SCAN SHOWED CEREBELLAR HEMORRHAGE: THE MRS SCORE AT DISCHARGE WAS 1. -A TOTAL OF 3 PATIENTS EXPERIENCED NEW-ONSET NEUROLOGICAL DEFICITS DURING THE FOLLOW-UP. TWO PATIENTS TREATED FOR VERTEBRAL ANEURYSMS PRESENTED ONE-SIDED MOTOR WEAKNESS DURING THE FOLLOW-UP AT 7 AND 24 MONTHS, RESPECTIVELY. THE MRS AT THE LAST FOLLOW-UP WAS 3 AND 4, RESPECTIVELY. -THE FAVORABLE OUTCOME RATE AT FOLLOW-UP WAS 54/62. THE COMPLICATION-FREE CUMULATIVE SURVIVAL RATES AT 1 AND 5 YEARS WERE 86.8 AND 82.0%, RESPECTIVELY. THE OVERALL CUMULATIVE SURVIVAL RATES AT 1 AND 5 YEAR WERE 96.5 AND 89.8%, RESPECTIVELY. -ANGIOGRAPHY FOLLOW-UP WAS AVAILABLE FOR 36 ANEURYSMS AT THE MEDIAN OF 6.0 MONTHS. OF THE 36 ANEURYSMS, 28 ANEURYSMS DEMONSTRATED COMPLETE OCCLUSION (GRADE 1 OF THE RAYMOND¿ROY GRADING SCALE) AND 34 ANEURYSMS DEMONSTRATED ADEQUATE OCCLUSION (GRADES 1 AND 2 OF THE RAYMOND¿ROY GRADING SCALE). TWO ANEURYSMS WERE RECANALIZED AND SUBSEQUENTLY RECEIVED THE RETREATMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2223846	PIPELINE	INTRACRANIAL ANEURYSM FLOW DIVERTER	OUT	MICRO THERAPEUTICS, INC. DBA EV3	NV UNK PIPELINE	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown	Death