STENT - VASCULAR RECONSTRUCTION
Report
- Report Number
- 1226348-2018-00556
- Event Type
- Injury
- Date Received
- May 9, 2018
- Date of Event
- May 31, 2016
- Report Date
- April 18, 2018
- Manufacturer
- CODMAN AND SHURTLEFF, INC
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
MANUFACTURER¿S REF. NO: (B)(4). THE ARTICLE (14 PAGES) AND THE SPREADSHEET COULD NOT BE ADDED AND SUBMIT WITH THE INITIAL REPORT. (B)(4).
MANUFACTURER¿S REF. NO: (B)(4). THE ARTICLE (14 PAGES) COULD NOT BE ADDED AND SUBMITTED WITH THE INITIAL REPORT. (B)(4).
MANUFACTURER¿S REF. NO: (B)(4). DUE TO THE SYSTEM TEMPORARY MEMORY ISSUE, THERE ARE PAGES (4, 8, AND 9) IN THE ARTICLES WITH ANGIOGRAPHIC IMAGES THAT CANNOT BE SENT VIA ATTACHMENTS, THE LINK TO THE ARTICLE IS BEING SUBMITTED TO SHOW THE COMPLETE ARTICLE. LINK: HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0180079.
MANUFACTURER¿S REF. NO: (B)(4). THE ARTICLE (14 PAGES) COULD NOT BE ADDED AND SUBMIT WITH THE INITIAL REPORT. (B)(4).
(B)(4). THE LITERATURE ARTICLE WAS FOUND DURING A RECENT POST-MARKET SURVEILLANCE REVIEW (PMS) OF THIS DEVICE. THE CITATION IS AS FOLLOW: WANG C-C, FANG Y-B, ZHANG P, ZHU X, HONG B, XU Y, ET AL. (2017) RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF VERTEBRAL ARTERY DISSECTING ANEURYSMS WITH THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) DEVICE. PLOS ONE 12(6): E0180079. HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0180079. 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. INITIAL REPORTER FACILITY NAME: DEPARTMENT OF NEUROSURGERY, (B)(6). [COMPLAINT CONCLUSION]: THE DELAYED THROMBOEMBOLIC EVENT WAS CAPTURED IN THE LITERATURE PUBLICATION WANG C-C, FANG Y-B, ZHANG P, ZHU X, HONG B, XU Y, ET AL. (2017) ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF VERTEBRAL ARTERY DISSECTING ANEURYSMS WITH THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) DEVICE.¿ PLOS ONE 12(6): E0180079. HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0180079. THE PATIENT IS A (B)(6)-YEAR OLD MALE WHO EXPERIENCED HEMIPLEGIA AND HYPOESTHESIA OF FACE AND HEMI-LATERAL BODY TWO MONTHS AFTER UNDERGOING A DOUBLE STENTING PROCEDURE ON THE 20.6 MM (LENGTH) X 5.3 MM (DIAMETER) VADA IN WHICH ONE LVIS 3.5, 212525-CAS AND ONE 4.5×37 ENTERPRISE STENT WERE DEPLOYED (THERE WAS NO DEVICE SPECIFIC INFORMATION PROVIDED IN THE ARTICLE, INCLUDING DEVICE CATALOG AND LOT NUMBERS.); THE INITIAL RAYMOND GRADE WAS 3. THE EVENT OCCURRED ONE WEEK AFTER CLOPIDOGREL WAS DISCONTINUED AND THE PATIENT INITIALLY PRESENTED WITH DIZZINESS. DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (DW-MRI) DEMONSTRATED MULTIPLE INFARCTIONS AT THE CEREBELLAR AND PARIETAL LOBE. THE PATIENT¿S EMERGENT DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) REVEALED COMPLETE IN-STENT THROMBOSIS AND TOTAL OCCLUSION OF VERTEBRAL ARTERY V4 SEGMENT. INTRA-ARTERIAL (IA) THROMBOLYSIS USING IIB-IIIA INHIBITOR (TIROFIBAN) PERFUSION VIA MICROCATHETER WAS PERFORMED BUT FAILED. THE MICROCATHETER WAS ALSO UNSUCCESSFUL IN PENETRATING THE OCCLUSION TO THE DISTAL END FOR THROMBECTOMY. THROMBOELASTOGRAPHY PERFORMANCE WAS EVALUATED TO TEST PLATELET INHIBITION AND A POOR RESPONSE (PLATELET AGGREGATION INHIBITION < 30%) TO ASPIRIN WAS FOUND. CLOPIDOGREL WAS RESUMED AND MAGNETIC RESONANCE ANGIOGRAPHY (MRA) AT SIX-MONTH FOLLOW-UP SHOWED THE OCCLUSION AS BEFORE; THE PATIENT¿S FINAL FOLLOW-UP MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE FEASIBILITY, SAFETY, AND EFFICACY OF THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) DEVICE IN RECONSTRUCTIVE TREATMENT OF VERTEBRAL ARTERY DISSECTING ANEURYSMS (VADAS) BY RETROSPECTIVE REVIEW OF ALL PATIENTS WITH VADAS WHO HAD BEEN TREATED WITH RECONSTRUCTIVE TECHNIQUE USING THE LVIS STENT BETWEEN JUNE 2014 TO MAY 2016. A TOTAL OF 38 PATIENTS (25 MEN AND 13 WOMEN WITH A MEAN AGE OF 53.7 YEARS; RANGE 31 - 73 YEARS) WITH VADAS WHO UNDERWENT TREATMENT WITH LVIS STENT WERE IDENTIFIED, INCLUDING 3 RUPTURED VADAS. RECONSTRUCTIVE TREATMENT INCLUDED STENT-ASSISTED COILING OR ENDOVASCULAR STENTING ONLY. STENTING ONLY WAS INDICATED FOR ANEURYSMS WITH IMPORTANT SIDE BRANCHES INVOLVED AND/OR NO OBVIOUS ANEURYSMAL DILATION. THE AIM OF THE VADA TREATMENT WAS THE COMPLETE EMBOLIZATION OR OBVIOUS CONTRAST STASIS. FIVE ENTERPRISE STENTS WERE SIMULTANEOUSLY USED WITH SINGLE OR DOUBLE LVIS STENT(S) IN FIVE PATIENTS. PATIENT RISK FACTORS INCLUDED HYPERTENSION, DYSLIPIDEMIA, DIABETES, AND SMOKING. A LOADING DOSE OF CLOPIDOGREL AND ASPIRIN (300 MG EACH) WAS ADMINISTERED ORALLY BY GASTROINTESTINAL TUBE OR PER RECTUM TWO HOURS BEFORE THE PROCEDURE. PATIENTS WITH UNRUPTURED VADAS WERE TREATED WITH 75 MG CLOPIDOGREL AND 100 MG ASPIRIN AT LEAST 3 DAYS BEFORE THE PROCEDURE. HEPARIN WAS ADMINISTERED INTRAVENOUSLY DURING THE PROCEDURE WITH THE GOAL OF ACHIEVING AN ACTIVATED CLOTTING TIME (ACT) OF 2-2.5 TIMES THAT OF BASELINE. PATIENTS WERE MAINTAINED ON DUAL ANTIPLATELET THERAPY FOR AT LEAST SIX WEEKS AND AFTER THAT ON ASPIRIN-ONLY INDEFINITELY. IMMEDIATE ANGIOGRAPHIC RESULTS SHOWED THAT ALL VADAS WERE SUCCESSFULLY TREATED WITH RECONSTRUCTIVE TECHNIQUES INCLUDING THE STENT-ASSISTED COILING (N = 34) AND STENTING ONLY (N=4). CLINICAL FOLLOW-UP AT 5-28 MONTHS WAS ACHIEVED IN 36 PATIENTS. TWO PATIENTS DIED DURING THE FOLLOW-UP PERIOD; ONE DIED FROM UNEXPLAINED INTRACEREBRAL HEMORRHAGE FIVE MONTHS AFTER THE PROCEDURE; THIS PATIENT UNDERWENT CONTRAST ENHANCED MRA (1.5T) FOLLOW-UP ONE MONTH AFTER THE PROCEDURE WHICH SHOWED A STABLE EMBOLIZATION OF THE ANEURYSM. THE HEMATOMA LOCATED AT THE CONTRALATERAL BASAL GANGLIA AND CONSIDERED IRRELEVANT TO THE TREATED ANEURYSM. ANTIPLATELET THERAPY AFTER STENT DEPLOYMENT MAY INCREASE RISK OF HEMORRHAGE WHICH SHOULD NOT BE EXCLUDE FROM ITS CAUSES. THE SECOND PATIENT DIED FROM PANCREATIC CARCINOMA ONE AND A HALF YEAR AFTER UNDERGOING ANEURYSM TREATMENT. IN THE 36 SURVIVING PATIENTS, THERE WAS NO NEW NEUROLOGIC DETERIORATION OR ANEURYSM RE-BLEEDING OBSERVED. THE STUDY CONCLUDED THAT PRELIMINARY EXPERIENCE WITH RECONSTRUCTION OF VADAS WITH THE LVIS DEVICE DEMONSTRATED THAT THE TREATMENT APPROACH IS FEASIBLE WITH GOOD SHORT-TERM ANGIOGRAPHIC AND CLINICAL OUTCOMES. THE COMPLEXITY OF THE TECHNIQUE AND INCREASED METAL COVERAGE RATE AND OVERLAPPING MULTIPLE STENTS COULD BE RELATED TO INCREASED ISCHEMIC COMPLICATIONS AND SHOULD BE TAKEN INTO CONSIDERATION BEFORE USING THE TECHNIQUE. LONG-TERM AND LARGER COHORT STUDIES ARE NEEDED TO VALIDATE THE RESULTS IN THIS STUDY. THE ENTERPRISE STENT REMAINED IMPLANTED AND IS THUS NOT AVAILABLE TO BE RETURNED 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. IN-STENT THROMBOSIS AND CEREBRAL INFARCTION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE ENTERPRISE STENT AND CEREBRAL STENTING PROCEDURES. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, THE LITERATURE PUBLICATION SUGGESTED THAT THE PATIENT DEVELOPED IN-STENT THROMBOSIS DUE TO POOR RESPONSE TO ASPIRIN. OF NOTE, THE EVENT OCCURRED ONE WEEK AFTER CLOPIDOGREL WAS DISCONTINUED. IT IS POSSIBLE THAT PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE EVENTS OF IN-STENT THROMBOSIS AND CEREBRAL INFARCTION ARE LIFE-THREATENING AND IN THIS CASE NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT. FURTHERMORE, THE RELATIONSHIP OF THE EVENT TO THE DEVICE OR PROCEDURE CANNOT BE EXCLUDED. THUS, THE EVENT MEETS THE CRITERIA FOR MDR REPORTABILITY AS A SERIOUS INJURY. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
THE DELAYED THROMBOEMBOLIC EVENT WAS CAPTURED IN THE LITERATURE PUBLICATION WANG C-C, FANG Y-B, ZHANG P, ZHU X, HONG B, XU Y, ET AL. (2017) ¿RECONSTRUCTIVE ENDOVASCULAR TREATMENT OF VERTEBRAL ARTERY DISSECTING ANEURYSMS WITH THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) DEVICE.¿ PLOS ONE 12(6): E0180079. HTTPS://DOI.ORG/10.1371/JOURNAL.PONE.0180079. THE PATIENT IS A (B)(6) YEAR OLD MALE WHO EXPERIENCED HEMIPLEGIA AND HYPOESTHESIA OF FACE AND HEMI-LATERAL BODY TWO MONTHS AFTER UNDERGOING A DOUBLE STENTING PROCEDURE ON THE 20.6 MM (LENGTH) X 5.3 MM (DIAMETER) VADA IN WHICH ONE LVIS 3.5, 212525-CAS AND ONE 4.5×37 ENTERPRISE STENT WERE DEPLOYED (THERE WAS NO DEVICE SPECIFIC INFORMATION PROVIDED IN THE ARTICLE, INCLUDING DEVICE CATALOG AND LOT NUMBERS.); THE INITIAL RAYMOND GRADE WAS 3. THE EVENT OCCURRED ONE WEEK AFTER CLOPIDOGREL WAS DISCONTINUED AND THE PATIENT INITIALLY PRESENTED WITH DIZZINESS. DIFFUSION-WEIGHTED MAGNETIC RESONANCE IMAGING (DW-MRI) DEMONSTRATED MULTIPLE INFARCTIONS AT THE CEREBELLAR AND PARIETAL LOBE. THE PATIENT¿S EMERGENT DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) REVEALED COMPLETE IN-STENT THROMBOSIS AND TOTAL OCCLUSION OF VERTEBRAL ARTERY V4 SEGMENT. INTRA-ARTERIAL (IA) THROMBOLYSIS USING IIB-IIIA INHIBITOR (TIROFIBAN) PERFUSION VIA MICROCATHETER WAS PERFORMED BUT FAILED. THE MICROCATHETER WAS ALSO UNSUCCESSFUL IN PENETRATING THE OCCLUSION TO THE DISTAL END FOR THROMBECTOMY. THROMBOELASTOGRAPHY PERFORMANCE WAS EVALUATED TO TEST PLATELET INHIBITION AND A POOR RESPONSE (PLATELET AGGREGATION INHIBITION < 30%) TO ASPIRIN WAS FOUND. CLOPIDOGREL WAS RESUMED AND MAGNETIC RESONANCE ANGIOGRAPHY (MRA) AT SIX-MONTH FOLLOW-UP SHOWED THE OCCLUSION AS BEFORE; THE PATIENT¿S FINAL FOLLOW-UP MODIFIED RANKIN SCALE (MRS) SCORE WAS 1. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE FEASIBILITY, SAFETY, AND EFFICACY OF THE LOW-PROFILE VISUALIZED INTRALUMINAL SUPPORT (LVIS) DEVICE IN RECONSTRUCTIVE TREATMENT OF VERTEBRAL ARTERY DISSECTING ANEURYSMS (VADAS) BY RETROSPECTIVE REVIEW OF ALL PATIENTS WITH VADAS WHO HAD BEEN TREATED WITH RECONSTRUCTIVE TECHNIQUE USING THE LVIS STENT BETWEEN JUNE 2014 TO MAY 2016. A TOTAL OF 38 PATIENTS (25 MEN AND 13 WOMEN WITH A MEAN AGE OF 53.7 YEARS; RANGE 31 - 73 YEARS) WITH VADAS WHO UNDERWENT TREATMENT WITH LVIS STENT WERE IDENTIFIED, INCLUDING 3 RUPTURED VADAS. RECONSTRUCTIVE TREATMENT INCLUDED STENT-ASSISTED COILING OR ENDOVASCULAR STENTING ONLY. STENTING ONLY WAS INDICATED FOR ANEURYSMS WITH IMPORTANT SIDE BRANCHES INVOLVED AND/OR NO OBVIOUS ANEURYSMAL DILATION. THE AIM OF THE VADA TREATMENT WAS THE COMPLETE EMBOLIZATION OR OBVIOUS CONTRAST STASIS. FIVE ENTERPRISE STENTS WERE SIMULTANEOUSLY USED WITH SINGLE OR DOUBLE LVIS STENT(S) IN FIVE PATIENTS. PATIENT RISK FACTORS INCLUDED HYPERTENSION, DYSLIPIDEMIA, DIABETES, AND SMOKING. A LOADING DOSE OF CLOPIDOGREL AND ASPIRIN (300 MG EACH) WAS ADMINISTERED ORALLY BY GASTROINTESTINAL TUBE OR PER RECTUM TWO HOURS BEFORE THE PROCEDURE. PATIENTS WITH UNRUPTURED VADAS WERE TREATED WITH 75 MG CLOPIDOGREL AND 100 MG ASPIRIN AT LEAST 3 DAYS BEFORE THE PROCEDURE. HEPARIN WAS ADMINISTERED INTRAVENOUSLY DURING THE PROCEDURE WITH THE GOAL OF ACHIEVING AN ACTIVATED CLOTTING TIME (ACT) OF 2-2.5 TIMES THAT OF BASELINE. PATIENTS WERE MAINTAINED ON DUAL ANTIPLATELET THERAPY FOR AT LEAST SIX WEEKS AND AFTER THAT ON ASPIRIN-ONLY INDEFINITELY. IMMEDIATE ANGIOGRAPHIC RESULTS SHOWED THAT ALL VADAS WERE SUCCESSFULLY TREATED WITH RECONSTRUCTIVE TECHNIQUES INCLUDING THE STENT-ASSISTED COILING (N = 34) AND STENTING ONLY (N=4). CLINICAL FOLLOW-UP AT 5-28 MONTHS WAS ACHIEVED IN 36 PATIENTS. TWO PATIENTS DIED DURING THE FOLLOW-UP PERIOD; ONE DIED FROM UNEXPLAINED INTRACEREBRAL HEMORRHAGE FIVE MONTHS AFTER THE PROCEDURE; THIS PATIENT UNDERWENT CONTRAST ENHANCED MRA (1.5T) FOLLOW-UP ONE MONTH AFTER THE PROCEDURE WHICH SHOWED A STABLE EMBOLIZATION OF THE ANEURYSM. THE HEMATOMA LOCATED AT THE CONTRALATERAL BASAL GANGLIA AND CONSIDERED IRRELEVANT TO THE TREATED ANEURYSM. ANTIPLATELET THERAPY AFTER STENT DEPLOYMENT MAY INCREASE RISK OF HEMORRHAGE WHICH SHOULD NOT BE EXCLUDE FROM ITS CAUSES. THE SECOND PATIENT DIED FROM PANCREATIC CARCINOMA ONE AND A HALF YEAR AFTER UNDERGOING ANEURYSM TREATMENT. IN THE 36 SURVIVING PATIENTS, THERE WAS NO NEW NEUROLOGIC DETERIORATION OR ANEURYSM RE-BLEEDING OBSERVED. THE STUDY CONCLUDED THAT PRELIMINARY EXPERIENCE WITH RECONSTRUCTION OF VADAS WITH THE LVIS DEVICE DEMONSTRATED THAT THE TREATMENT APPROACH IS FEASIBLE WITH GOOD SHORT-TERM ANGIOGRAPHIC AND CLINICAL OUTCOMES. THE COMPLEXITY OF THE TECHNIQUE AND INCREASED METAL COVERAGE RATE AND OVERLAPPING MULTIPLE STENTS COULD BE RELATED TO INCREASED ISCHEMIC COMPLICATIONS AND SHOULD BE TAKEN INTO CONSIDERATION BEFORE USING THE TECHNIQUE. LONG-TERM AND LARGER COHORT STUDIES ARE NEEDED TO VALIDATE THE RESULTS IN THIS STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343225 | STENT - VASCULAR RECONSTRUCTION | INTRACRANIAL NEUROVASCULAR STENT | NJE | CODMAN AND SHURTLEFF, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |