STENT - VASCULAR RECONSTRUCTION
Report
- Report Number
- 1226348-2018-00558
- Event Type
- Injury
- Date Received
- May 11, 2018
- Date of Event
- November 17, 2011
- Report Date
- April 19, 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
(B)(4). WORLD NEUROSURG. (2016) 91: 218-227. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.024 ¿MAGNETIC RESONANCE IMAGING FOLLOW-UP OF LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS AFTER TOTAL EMBOLIZATION ON ANGIOGRAPHY.¿ 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. (B)(6). [COMPLAINT CONCLUSION]: THE EVENT WAS CAPTURED IN THE LITERATURE PUBLICATION WORLD NEUROSURG. (2016) 91: 218-227. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.024 ¿MAGNETIC RESONANCE IMAGING FOLLOW-UP OF LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS AFTER TOTAL EMBOLIZATION ON ANGIOGRAPHY.¿ IT WAS REPORTED THAT A (B)(6) MALE PATIENT FROM ¿CASE 1¿ PRESENTED WITH INTRACTABLE RIGHT HEMIFACIAL SPASM FOR 3 YEARS WAS ADMITTED TO THE STUDY INSTITUTION (DEPARTMENT OF NEUROSURGERY, (B)(6) HOSPITAL OF (B)(6)) ON (B)(6) 2011. INITIAL MAGNETIC RESONANCE IMAGING (MRI) SHOWED A DISSECTING ANEURYSM IN THE LOWER SEGMENT OF THE BASILAR ARTERY. THE PATIENT HAS A KNOWN HISTORY OF HYPERTENSION AND HAS BEEN A SMOKER FOR 10 YEARS. CEREBRAL ANGIOGRAPHY ON (B)(6) 2011, REVEALED TORTUOUS FUSIFORM DILATION OF THE BASILAR ARTERY AND INVOLVEMENT OF BILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERIES. ON (B)(6) 2011, THE PATIENT UNDERWENT RECONSTRUCTIVE ENDOVASCULAR REPAIR WITHOUT ANY COMPLICATIONS. DURING THE PROCEDURE, A 4.5 X 37 MM ENTERPRISE STENT (CERENOVUS, USA) WAS PLACED WITHIN A 5.5 X 50 CM LEO STENT (BALT EXTRUSION, (B)(4)) TO OVERLAP THE ENTIRE DISSECTED SEGMENT. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY FOR THREE MONTHS AND CONTINUED WITH 100 MG ASPIRIN DAILY THEREAFTER. THE PATIENT¿S RIGHT HEMIFACIAL SPASM COMPLETELY DISAPPEARED AFTER THE TREATMENT. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT HIS 5-MONTH FOLLOW-UP SHOWED GOOD REMODELING OF THE PARENT ARTERY. HOWEVER, THE PATIENT¿S SYMPTOMS WORSENED AT 22 MONTHS AFTER TREATMENT WITH THE DEVELOPMENT OF ATAXIA AND PARESIS OF THE FIFTH, SEVENTH, AND EIGHTH CRANIAL NERVES ON THE RIGHT SIDE. DSA REVEALED A STABLE GEOMETRIC SHAPE IN THE DISSECTED ARTERY. 3T (TESLA) HIGH-RESOLUTION MAGNETIC RESONANCE IMAGING (MRI) OF THE ARTERIAL WALL TAKEN 2 DAYS LATER DEMONSTRATED THAT A NEW INTRAMURAL HEMATOMA (IMH) MEASURING 15 X 20 MM HAD RESULTED IN FURTHER ENLARGEMENT OF THE LESION WITH MARKED COMPRESSION OF THE BRAINSTEM. THE ENLARGED MEDIAL DISSECTING HEMATOMA LINKED TO ELEVATED INTERNAL PRESSURE RESULTED IN RUPTURE OF THE ANEURYSM. CLINICAL DETERIORATION COULD BE EXPLAINED BY A CONCOMITANT ENLARGED DISSECTING ANEURYSM BECAUSE OF HEMORRHAGE INTO THE SUBADVENTITIAL THROMBUS AND ADJACENT BRAINSTEM AS WELL AS POTENTIAL PACKING OF THE ASSUMED PSEUDO-LUMEN. THE PATIENT¿S ASPIRIN THERAPY WAS DISCONTINUED AND HE WAS TRANSFERRED TO THE NEUROLOGY DEPARTMENT FOR CONSERVATIVE THERAPY. THE PATIENT SHOWED GRADUAL IMPROVEMENT OF NEUROLOGIC FUNCTION AND WAS DISCHARGED TWO WEEKS LATER WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 1. THERE WAS NO DEVICE SPECIFIC INFORMATION (INCLUDING DEVICE CATALOG AND LOT NUMBER) PROVIDED IN THE ARTICLE. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE OUTCOMES OF LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS (VBDAS) AFTER ENDOVASCULAR TOTAL EMBOLIZATION BY FOLLOW-UP 3T (TESLA) HIGH-RESOLUTION MRI. THE STUDY RETROSPECTIVELY ANALYZED AND EVALUATED 4 PATIENTS WHO HAD UNRUPTURED LARGE OR GIANT VBDAS THAT WERE TREATED WITH ENDOVASCULAR TECHNIQUES WITH TOTAL EMBOLIZATION OF THE ANEURYSMS BETWEEN NOVEMBER 2011 AND JULY 2015, CONFIRMED ON FOLLOW-UP ANGIOGRAPHY, BUT HAD UNRELIEVED OR WORSENED SYMPTOMS. 3T HIGH-RESOLUTION MRS IMAGES OF BEFORE AND AFTER TREATMENT WERE EVALUATED TO ASSESS ARTERIAL WALL EVOLUTION. PATIENTS MEDICATION WAS DETERMINED DEPENDING ON THE ENDOVASCULAR PROCEDURE PERFORMED. IF RECONSTRUCTIVE ENDOVASCULAR PROCEDURES WERE CHOSEN, THE PATIENT WAS PRE-MEDICATED WITH A DUAL ANTIPLATELET REGIMEN OF 75 MG CLOPIDOGREL AND 100 MG ASPIRIN DAILY FOR 5 DAYS BEFORE THE TREATMENT PROCEDURE THEN RECEIVED THE STENT-ASSISTED COILING OR PLACEMENT OF A STENT WITHOUT COILS. BOTH THE DISSECTING ANEURYSM AND THE PARENT ARTERY WERE OCCLUDED WITH COILS IF THE INTERNAL TRAPPING TECHNIQUE WAS CHOSEN. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) AND MAGNETIC RESONANCE ANGIOGRAPHY (MRA) WERE USED TO ANALYZE LUMEN EVOLUTION. MRI OR HIGH-RESOLUTION MRI OF BEFORE AND AFTER TREATMENT WAS USED TO ANALYZE VESSEL WALL EVOLUTION. HETEROGENOUS SIGNAL INTENSITIES IN THE ANEURYSM WALL AND THE ¿ONION SKIN-LIKE¿ ASPECT OF THE ANEURYSM WITH THICKENING WALL SUGGEST THE PRESENCE OF A PARTIALLY THROMBOSED IMH AT DIFFERENT STAGES OF EVOLUTION. DURING FOLLOW-UP, THE PRESENCE OF AN INCREASED DIAMETER OF THE DISSECTING ANEURYSM WAS NOTED AND COMPARED WITH THE DIAMETER OF THE ANEURYSM BEFORE THE ENDOVASCULAR PROCEDURE. LESION ENHANCEMENT PATTERNS WERE ANALYZED IF GADOLINIUM WAS USED. RESULTS OF ARTERY LUMEN ASSESSMENT BY ANGIOGRAPHY SHOWED THAT ALL 4 PATIENTS SHOWED RELATIVELY SATISFACTORY RESULTS DURING FOLLOW-UP. THE (B)(6) MALE PATIENT IN ¿CASE 1¿ WAS TREATED BY STENT REPLACEMENT WITHOUT COILS HAD FOLLOW-UP IMAGING AT 5 MONTHS AND 22 MONTHS SHOWED A WELL-CONSTRUCTED DISSECTING ARTERY ALTHOUGH HE SHOWED WORSENING SYMPTOMS AT THE 22-MONTH FOLLOW-UP. LUMINAL RECONSTRUCTION OR OCCLUSION HAVE BEEN THE FOCUS OF MOST REPORTS FOLLOWING PROCEDURES. HOWEVER, IT IS NOT KNOWN WHETHER ARTERIAL WALL REMAINS STABLE, RECOVERS, OR BECAME PROGRESSIVELY WORSEN AFTER SUCCESSFUL ENDOVASCULAR TREATMENT. THE 4 CASES IN THIS STUDY HAD FOLLOW-UP ANGIOGRAPHY THAT CONFIRMED SATISFACTORY LUMINAL RESULTS, BUT FOLLOW-UP WITH HIGH-RESOLUTION MRI SHOWED NEW HEMATOMA OR PERSISTENT EXISTENCE OF HEMORRHAGIC SIGNALS IN THE DISSECTING WALL AND IN 3 OF THE 4 CASES ¿ INCREASED ANEURYSM SIZE. THE RESULTS CAPTURE A DISCREPANCY BETWEEN THE ARTERIAL WALL AND THE LUMEN AFTER ENDOVASCULAR TREATMENT THAT MIGHT BE A REASON TO RE-EVALUATE THE EFFICACY OF THE TREATMENT FOR THESE LESIONS. THE FORMATION OF AN IMH IS A CRITICAL EVENT NECESSARY FOR A DISSECTING ANEURYSM TO PROGRESS; THIS CAN BE MONITORED ON MRI. RECURRENT IMH CAN CAUSE DISSECTING ANEURYSMS TO GROW OR RUPTURE, BUT THE MECHANISM IS UNCLEAR. ONE OF THE HYPOTHESES APPLICABLE TO THE PATIENT IN ¿CASE 1¿ IS THAT THE PATENT CHANNELS MAY REMAIN IN THE THROMBOSED DISSECTED LUMENS THAT MAINTAIN BLOOD INFLOW FROM PERFORATORS AFTER STENT PLACEMENT. THE PATIENT IN ¿CASE 1¿ WHERE THE DISSECTED ARTERY WAS RESHAPED, A NEW IMH WITH HIGHER SIGNAL INTENSITY WAS IDENTIFIED INSIDE THE POSTERIOR LATERAL PORTION OF THE ANEURYSM WALL; THIS HIGHER SIGNAL INTENSITY REFLECTS THE DYNAMIC NATURE OF DISSECTING ANEURYSMS. THE ENLARGED MEDIAL DISSECTING HEMATOMA LINKED TO ELEVATED INTERNAL PRESSURE RESULTED IN THE RUPTURE OF THE ANEURYSM. THE CLINICAL DETERIORATION COULD BE EXPLAINED BY A CONCOMITANT ENLARGED DISSECTING ANEURYSM BECAUSE OF HEMORRHAGE INTO THE SUBADVENTITIAL THROMBUS AND ADJACENT BRAINSTEM AS WELL AS POTENTIAL PACKING OF THE ASSUMED PSEUDO-LUMEN. INTERNAL TRAPPING WITH COILS HAS BEEN PROVEN TO BE A STABLE AND DURABLE TREATMENT FOR CLOSURE OF VBDAS, BUT IT REQUIRES ADEQUATE COLLATERAL FLOW AND INVOLVEMENT OF AN IMPORTANT PERFORATING BRANCH ARTERY IS A CONTRAINDICATION. THIS TREATMENT MODALITY WAS UNSUITABLE FOR THE PATIENT IN ¿CASE 1,¿ IN WHICH BILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERIES WERE INVOLVED. THE RARITY OF LARGE OR GIANT VBDAS IS THE LIMITATION OF THIS STUDY AS IT RESULTED IN ONLY 4 CASES ANALYZED. A PROSPECTIVE, MULTICENTER INVESTIGATION WITH A LARGE SAMPLE SIZE IS WARRANTED. THE STUDY CONCLUDED THAT THE EFFICACY OF CONVENTIONAL ENDOVASCULAR TREATMENT FOR LARGE OR GIANT VBDAS IS UNCERTAIN. ANGIOGRAPHY-ONLY AT FOLLOW-UP DOES NOT PROVIDE ADEQUATE PREDICTION OF OUTCOME. A WORTHWHILE ADJUNCT TO FOLLOW THESE LESIONS IS HIGH-RESOLUTION MRI. ANEURYSM RUPTURE AND NEUROLOGICAL DEFICIT ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE ENTERPRISE VRD AND STENT-ASSISTED COIL EMBOLIZATION PROCEDURES. THE PUBLICATION STATES THAT PATIENTS WITH LARGE OR GIANT VBDAS ARE CLINICALLY CHALLENGING. THE NATURAL HISTORY IS POOR, ESPECIALLY WHEN THE ANEURYSM IS SYMPTOMATIC BY MASS EFFECT. DISSECTING ANEURYSMS MAY GROW OR RUPTURE BECAUSE OF RECURRENT IMH, BUT THE MECHANISM IS UNCLEAR. ONE HYPOTHESIS IS THAT PATENT CHANNELS MAY REMAIN IN THE THROMBOSED DISSECTED LUMENS THAT MAINTAIN BLOOD INFLOW FROM PERFORATORS AFTER STENT PLACEMENT. AS OUTLINED IN THE IFU, THE INDICATED USE OF THE ENTERPRISE VRD IS TO PREVENT COILS FROM PROTRUDING OUT OF THE ANEURYSM INTO THE PARENT ARTERY. IN ADDITION, IT PRECAUTIONS THAT THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPED STENTS HAS NOT BEEN ESTABLISHED. IT IS ALSO GENERALLY CONTRAINDICATED IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT DUE TO SEVERE INTRACRANIAL VESSEL TORTUOSITY. THE ROOT CAUSE OF THE EVENTS CANNOT BE DETERMINED; HOWEVER, IT IS POSSIBLE THAT VESSEL CHARACTERISTICS, PROCEDURAL FACTORS, AND THE COMPLEX NATURE OF THE PATIENT¿S UNDERLYING DISEASE (INCLUDING KNOWN HISTORY OF HYPOTENSION AND SMOKING) MAY HAVE CONTRIBUTED TO THE RUPTURE AND SUBSEQUENT NEUROLOGICAL COMPLICATIONS. THE PUBLICATION ALSO INFERRED THAT THE ENLARGED MEDIAL DISSECTING HEMATOMA LINKED TO ELEVATED INTERNAL PRESSURE RESULTED IN RUPTURE OF THE ANEURYSM. THE POSITIVE ASSOCIATION BETWEEN ANEURYSM GROWTH, ANEURYSM SIZE, AND CIGARETTE SMOKING SUGGESTS THAT THE COMBINATION OF THESE FACTORS ARE ASSOCIATED WITH AN INCREASED RISK OF RUPTURE AND MAY INFLUENCE THE NEED FOR THERAPEUTIC INTERVENTION. THESE EVENTS ARE SERIOUS/LIFE-THREATENING, REQUIRED CONSERVATIVE TREATMENT TO PREVENT PERMANENT IMPAIRMENT, AND THE RELATIONSHIP OF THE EVENTS TO THE DEVICE OR PROCEDURE CANNOT BE EXCLUDED. THUS, THE EVENTS MEET THE CRITERIA FOR MDR REPORTING 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. (B)(4).
THE EVENT WAS CAPTURED IN THE LITERATURE PUBLICATION WORLD NEUROSURG. (2016) 91: 218-227. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.024 ¿MAGNETIC RESONANCE IMAGING FOLLOW-UP OF LARGE OR GIANT VERTEBROBASILAR DISSECTING ANEURYSMS AFTER TOTAL EMBOLIZATION ON ANGIOGRAPHY.¿ IT WAS REPORTED THAT A (B)(6) MALE PATIENT FROM ¿CASE 1¿ PRESENTED WITH INTRACTABLE RIGHT HEMIFACIAL SPASM FOR 3 YEARS WAS ADMITTED TO THE STUDY INSTITUTION (DEPARTMENT OF NEUROSURGERY, (B)(6) HOSPITAL OF (B)(6)) ON (B)(6) 2011. INITIAL MAGNETIC RESONANCE IMAGING (MRI) SHOWED A DISSECTING ANEURYSM IN THE LOWER SEGMENT OF THE BASILAR ARTERY. THE PATIENT HAS A KNOWN HISTORY OF HYPERTENSION AND HAS BEEN A SMOKER FOR 10 YEARS. CEREBRAL ANGIOGRAPHY ON (B)(6) 2011, REVEALED TORTUOUS FUSIFORM DILATION OF THE BASILAR ARTERY AND INVOLVEMENT OF BILATERAL ANTERIOR INFERIOR CEREBELLAR ARTERIES. ON (B)(6) 2011, THE PATIENT UNDERWENT RECONSTRUCTIVE ENDOVASCULAR REPAIR WITHOUT ANY COMPLICATIONS. DURING THE PROCEDURE, A 4.5 X 37 MM ENTERPRISE STENT (CERENOVUS, USA) WAS PLACED WITHIN A 5.5 X 50 CM LEO STENT (BALT EXTRUSION, (B)(6)) TO OVERLAP THE ENTIRE DISSECTED SEGMENT. THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY FOR THREE MONTHS AND CONTINUED WITH 100 MG ASPIRIN DAILY THEREAFTER. THE PATIENT¿S RIGHT HEMIFACIAL SPASM COMPLETELY DISAPPEARED AFTER THE TREATMENT. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) PERFORMED AT HIS 5-MONTH FOLLOW-UP SHOWED GOOD REMODELING OF THE PARENT ARTERY. HOWEVER, THE PATIENT¿S SYMPTOMS WORSENED AT 22 MONTHS AFTER TREATMENT WITH THE DEVELOPMENT OF ATAXIA AND PARESIS OF THE FIFTH, SEVENTH, AND EIGHTH CRANIAL NERVES ON THE RIGHT SIDE. DSA REVEALED A STABLE GEOMETRIC SHAPE IN THE DISSECTED ARTERY. 3T (TESLA) HIGH-RESOLUTION MAGNETIC RESONANCE IMAGING (MRI) OF THE ARTERIAL WALL TAKEN 2 DAYS LATER DEMONSTRATED THAT A NEW INTRAMURAL HEMATOMA (IMH) MEASURING 15 X 20 MM HAD RESULTED IN FURTHER ENLARGEMENT OF THE LESION WITH MARKED COMPRESSION OF THE BRAINSTEM. THE ENLARGED MEDIAL DISSECTING HEMATOMA LINKED TO ELEVATED INTERNAL PRESSURE RESULTED IN RUPTURE OF THE ANEURYSM. CLINICAL DETERIORATION COULD BE EXPLAINED BY A CONCOMITANT ENLARGED DISSECTING ANEURYSM BECAUSE OF HEMORRHAGE INTO THE SUBADVENTITIAL THROMBUS AND ADJACENT BRAINSTEM AS WELL AS POTENTIAL PACKING OF THE ASSUMED PSEUDO-LUMEN. THE PATIENT¿S ASPIRIN THERAPY WAS DISCONTINUED AND HE WAS TRANSFERRED TO THE NEUROLOGY DEPARTMENT FOR CONSERVATIVE THERAPY. THE PATIENT SHOWED GRADUAL IMPROVEMENT OF NEUROLOGIC FUNCTION AND WAS DISCHARGED TWO WEEKS LATER WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 1. THERE WAS NO DEVICE SPECIFIC INFORMATION (INCLUDING DEVICE CATALOG AND LOT NUMBER) PROVIDED IN THE ARTICLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349554 | STENT - VASCULAR RECONSTRUCTION | INTRACRANIAL NEUROVASCULAR STENT | NJE | CODMAN AND SHURTLEFF, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |