THROMBECTOMY

Report

Report Number: 1226348-2018-00651
Event Type: Injury
Date Received: July 30, 2018
Date of Event: June 30, 2014
Report Date: July 11, 2018
Manufacturer: SEE H.10
Product Code: NRY
PMA / PMN Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER¿S REF. (B)(4). THIS LITERATURE ARTICLE AND SUBSEQUENT COMPLAINT WAS FOUND DURING A RECENT POST-MARKET SURVEILLANCE REVIEW (PMS) OF THIS DEVICE. THE CITATION IS AS FOLLOWS: ¿IMPACT AND EFFECTIVENESS OF DUAL ASPIRATION TECHNIQUE IN STENT - ASSISTED MECHANICAL THROMBECTOMY: RECENT IMPROVEMENTS IN ACUTE STROKE MANAGEMENT.¿ S. HOPF-JENSEN-M. PREISS-L. MARQUES-S. LEHRKE-J. SCHATTSCHNEIDER-H. STOLZE-S. MÜLLER-HÜLSBECK - CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY ¿ 2016 DOI 10.1007/S00270-016-1404-4. SPECIFIC INFORMATION REGARDING THIS PATIENT AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. THIS MDR REPORT IS BEING SUBMITTED WITH NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBER PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. [CONCLUSION]: THE LITERATURE ARTICLE ¿IMPACT AND EFFECTIVENESS OF DUAL ASPIRATION TECHNIQUE IN STENT - ASSISTED MECHANICAL THROMBECTOMY: RECENT IMPROVEMENTS IN ACUTE STROKE MANAGEMENT.¿ S. HOPF-JENSEN-M. PREISS-L. MARQUES-S. LEHRKE-J. SCHATTSCHNEIDER-H. STOLZE-S. MÜLLER-HÜLSBECK - CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY ¿ 2016, DOCUMENTED A PATIENT WHO PARTICIPATED IN THE MONOASPIRATION TECHNIQUE (MAT) ARM OF THE STUDY AND EXPERIENCED POSTOPERATIVE SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THERE WERE 30 PATIENTS IN THE MAT ARM OF THE STUDY; THE REVIVE STENT RETRIEVER WAS USED IN 13.3% OF THE PATIENTS IN THE MAT GROUP. THE ARTICLE DID NOT INDICATE IF THE REVIVE STENT RETRIEVER HAD BEEN USED WITH THIS PATIENT. HOWEVER, CERENOVUS TAKES A CONSERVATIVE APPROACH TO REPORT THIS EVENT SINCE THE REVIVE STENT RETRIEVER WAS USED IN SOME OF THE PATIENTS IN THE STUDY. NO SPECIFIC PATIENT, PROCEDURE OR DEVICE RELATED INFORMATION, INCLUDING CATALOG AND LOT NUMBER WAS PROVIDED IN THE ARTICLE. IMPROVEMENT IN THE TREATMENT OF ACUTE ISCHEMIC STROKE BECOMES IMPORTANT IN THE INCREASING ELDERLY POPULATION WITHIN THE EXPECTED DEMOGRAPHIC CHANGE. STENT RETRIEVERS HAVE BECOME THE STANDARD TREATMENT FOR ENDOVASCULAR STROKE MANAGEMENT AND CAN BE APPLIED IN CONJUNCTION WITH ASPIRATION TECHNIQUE. SEVERAL STUDIES HAVE DEMONSTRATED THE FEASIBILITY OF USING RETRIEVABLE STENTS TO EXTRACT THROMBOTIC MATERIAL FROM OCCLUDED INTRACRANIAL VESSELS. NEVERTHELESS, ESCALATING TREATMENT OPTIONS FOR OCCLUSIONS, WHICH ARE REFRACTORY TO FIRST-LINE SINGLE STENT RETRIEVER MECHANICAL THROMBECTOMY ARE NECESSARY. THERE ARE TWO MAIN METHODS OF ENDOVASCULAR MECHANICAL THROMBECTOMY. THE FIRST ONE IS THE REMOVAL OF THROMBI WITH RETRIEVAL DEVICES AND THE SECOND METHOD IS ASPIRATION OF OCCLUSIVE THROMBI WITH SUCTION DEVICES. COMBINING MECHANICAL RETRIEVAL AND IMPROVED ASPIRATION TECHNOLOGY IS AN INCREASINGLY USED APPROACH. THE PURPOSE OF THE STUDY IN THE LITERATURE ARTICLE WAS TO EVALUATE THE FEASIBILITY AND IMPACT OF DUAL ASPIRATION TECHNIQUE (DAT) WITHIN STENT-ASSISTED MECHANICAL THROMBECTOMY ON PROCEDURAL PARAMETERS AND CLINICAL OUTCOME. DURING A 16-MONTH PERIOD, BETWEEN JANUARY 2013 AND JUNE 2014, THERE WERE 76 CONSECUTIVE PATIENTS (MEAN AGE 70.7 YEAR; RANGE 33-89) WHO PRESENTED WITH ACUTE STROKE AND WERE TREATED WITHIN 6 HOURS WITH STENT-ASSISTED MECHANICAL THROMBECTOMY. THERE WERE 52 PATIENTS (68.4% WITH OCCLUSION IN THE ANTERIOR VESSEL THAT WERE ENROLLED IN THIS STUDY. OF THE 52 PATIENTS, 22 PATIENTS (48.3%) UNDERWENT THE DUAL ASPIRATION TECHNIQUE (DAT) AND 30 PATIENTS (57.7%) UNDERWENT THE MONOASPIRATION TECHNIQUE (MAT). THE ARTICLE NOTED THAT THE MAT PROCEDURE WAS PERFORMED PREDOMINANTLY AT NIGHT AND THE DAT PROCEDURE WAS OFTEN PERFORMED DURING THE NORMAL WORKING HOURS. PATIENTS WHO PRESENTED WITHIN THE 4.5-HOUR TIME WINDOW AT THE INITIAL COMPUTED TOMOGRAPHY (CT) AND COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WERE ADDITIONALLY TREATED WITH INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (TPA) (0.9 MG/KG RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (RTPA)) AFTER EXCLUSION OF CONTRAINDICATION. EPIDEMIOLOGICAL DATA, CLINICAL AND IMAGING CHARACTERISTICS (MODIFIED RANKIN SCORE (MRS), NIH STROKE SCALE/SCORE (NIHSS), ALBERTA STROKE PROGRAM EARLY CT SCORE (ASPECTS) AS WELL AS PROCEDURAL DETAILS WERE ANALYZED (THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) NUMBER OF RETRIEVAL, PROCEDURE TIME). CLINICAL OUTCOME WAS DETERMINED WITH MRS AT DISCHARGE AND AFTER 90 DAYS. THERE WAS ONE CASE OF POSTOPERATIVE SYMPTOMATIC INTRACRANIAL HEMORRHAGE REPORTED IN THE MAT GROUP AND NONE IN THE DAT GROUP. THE IN-HOSPITAL MORTALITY WAS 30% (9 PATIENTS) IN THE MAT GROUP VERSUS 22.7% (5 PATIENTS) IN THE DAT GROUP, WHICH LEAVE 38 PATIENTS FOR EVALUATION AT 3-MONTH FOLLOW-UP. THE MEAN MRS AT DISCHARGE DID NOT DIFFER BETWEEN THE MAT AND DAT GROUPS. CLINICAL OUTCOME IMPROVED IN FOLLOW-UP AFTER 3 MONTHS. IN THE MAT GROUP, 53.3% OF THE PATIENT REACHED AN INDEPENDENT STATUS (MRS = 2) VERSUS 54.5% IN THE DAT GROUP. THE ARTICLE CONCLUDED THAT THE DUAL ASPIRATION TECHNIQUE (DAT) WITH AN ADDITIONAL INTERMEDIATE GUIDE CATHETER PLACED CLOSED TO THE STENT RETRIEVER LEADS TO DECREASED PROCEDURE TIME IN THE ANTERIOR CIRCULATION. EVEN IN CASES WITH HIGHER THROMBUS LOAD, THE CLINICAL OUTCOME IS IMPROVED WHEN TREATED WITH THE DUAL ASPIRATION TECHNIQUE. THE DAT WAS FOUND TO BE EFFECTIVE AND SAFE IN ACHIEVING FAST RECANALIZATION AND FAVORABLE OUTCOME. HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE REVIVE SE AND THROMBECTOMY PROCEDURES. THE ROOT CAUSE OF THE HEMORRHAGE COULD NOT BE DETERMINED BASED ON THE MINIMAL INFORMATION PROVIDED IN THE ARTICLE. PATIENT, PROCEDURAL FACTORS OR CONCOMITANT DEVICES MAY HAVE CONTRIBUTED TO THE EVENT. IN ADDITION, IF THE PATIENT HAD RECEIVED TPA, THE SEVERITY OF THE HEMORRHAGE WOULD HAVE BEEN INCREASED. IN ADDITION, IT CANNOT BE CONFIRMED THAT THE REVIVE SE WAS USED IN THE PATIENT THAT EXPERIENCED THE HEMORRHAGE. SINCE CEREBRAL HEMORRHAGE IS A SERIOUS INJURY THAT CAN LEAD TO DEATH, THIS EVENT MEETS MDR REPORTING CRITERIA. THE REVIVE STENT RETRIEVER IS NOT AVAILABLE FOR EVALUATION. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. (B)(4).

Description of Event or Problem · 1

THE LITERATURE ARTICLE ¿IMPACT AND EFFECTIVENESS OF DUAL ASPIRATION TECHNIQUE IN STENT - ASSISTED MECHANICAL THROMBECTOMY: RECENT IMPROVEMENTS IN ACUTE STROKE MANAGEMENT.¿ S. HOPF-JENSEN-M. PREISS-L. MARQUES-S. LEHRKE-J. SCHATTSCHNEIDER-H. STOLZE-S. MÜLLER-HÜLSBECK - CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY ¿ 2016, DOCUMENTED A PATIENT WHO PARTICIPATED IN THE MONOASPIRATION TECHNIQUE (MAT) ARM OF THE STUDY AND EXPERIENCED POSTOPERATIVE SYMPTOMATIC INTRACRANIAL HEMORRHAGE. THERE WERE 30 PATIENTS IN THE MAT ARM OF THE STUDY; THE REVIVE STENT RETRIEVER WAS USED IN 13.3% OF THE PATIENTS IN THE MAT GROUP. THE ARTICLE DID NOT INDICATE IF THE REVIVE STENT RETRIEVER HAD BEEN USED WITH THIS PATIENT. HOWEVER, CERENOVUS TAKES A CONSERVATIVE APPROACH TO REPORT THIS EVENT SINCE THE REVIVE STENT RETRIEVER WAS USED IN SOME OF THE PATIENTS IN THE STUDY. NO SPECIFIC PATIENT, PROCEDURE OR DEVICE RELATED INFORMATION, INCLUDING CATALOG AND LOT NUMBER WAS PROVIDED IN THE ARTICLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
575405	THROMBECTOMY	EMBOLECTOMY CATHETER	NRY	SEE H.10

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other