ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2011-00358
- Event Type
- Injury
- Date Received
- July 15, 2011
- Date of Event
- May 27, 2011
- Report Date
- June 15, 2011
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. A TOTAL OF TWENTY-ONE (21) COMPLAINTS WERE CREATED TO CAPTURE THE EVENTS IN THIS ARTICLE: SIX EACH (6/21) WERE CAPTURED AS INCOMPLETE EXPANSION; TWELVE (12/21) WERE CAPTURED AS INCOMPLETE EXPANSION WITH CEREBRAL ARTERY EMBOLIZATION; AND THREE (3/21) WERE CAPTURED AS CEREBRAL ARTERY EMBOLIZATION ONLY. INCOMPLETE EXPANSION ONLY: (B)(4). INCOMPLETE EXPANSION WITH CEREBRAL ARTERY EMBOLIZATION: (B)(4). CEREBRAL ARTERY EMBOLIZATION ONLY: (B)(4). THE COMPLAINT RECEIVED STATES THAT THERE WAS INCOMPLETE ENTERPRISE STENT APPOSITION POST IMPLANTATION. AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: MALEK ET AL IN "CRESCENT SIGN ON MAGNETIC RESONANCE ANGIOGRAPHY REVEALING INCOMPLETE STENT APPOSITION: CORRELATION WITH DIFFUSION-WEIGHTED CHANGES IN STENT-MEDICATED COIL EMBOLIZATION OF ANEURYSMS"; DOI: 10.3171/2011.4.JNS102050. THE ARTICLE REPORTED INCOMPLETE ENTERPRISE STENT APPOSITION ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL LESIONS POST TREATMENT OF UNRUPTURED ANEURYSMS. A DISTINCTIVE SEMILUNAR SIGNAL PATTERN, IDENTIFIED USING 3-T MR ANGIOGRAPHY, REPRESENTED FLOW OUTSIDE THE CONFINES OF THE ENTERPRISE STENT STRUT. THIS PATTERN, DESIGNATED AS THE CRESCENT SIGN, WAS CONFIRMED TO CORRESPOND TO INCOMPLETE STENT APPOSITION BY USE OF HIGH-RESOLUTION ANGIOGRAPHIC FLAT-PANEL CT SCANNING REVEALING FLOW INGRESS INTO AND EGRESS OUT OF THE ISOLATED LUMINAL WEDGE. THE INCOMPLETE STENT APPOSITION WAS ALSO ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL HYPERINTENSE LESIONS ON DIFFUSION WEIGHTED IMAGING. THESE RESULTS IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE PATIENT DID NOT SUFFER ANY IRREVERSIBLE CLINICAL DEFICIT ATTRIBUTED TO THE LESIONS NOTED ON DIFFUSION-WEIGHTED IMAGING BY THE TIME OF DISCHARGE. THE CRESCENT SIGN WAS STRONGLY PREDICTIVE OF IPSILATERAL POSTPROCEDURAL LESIONS SEEN ON DIFFUSION-WEIGHTED IMAGING IN THE ENTIRE POPULATION INCOMPLETE STENT APPOSITION IS DETECTABLE ON 3-T MR ANGIOGRAPHY AS A CRESCENT SIGN, AND WAS FOUND TO BE HIGHLY PREVALENT IN ENTERPRISE CLOSED-CELL DESIGN STENTS USED TO ASSIST COIL EMBOLIZATION OF ANEURYSMS. THE RESULTS OF THE STUDY IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. STENT MALAPPOSITION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. WHILE MALAPPOSITION IS NOT SPECIFICALLY NOTED IN THE ENTERPRISE IFU, INCOMPLETE ANEURYSM OCCLUSION, FAILURE TO DELIVER THE STENT TO THE INTENDED SITE AND STENT THROMBOSIS ARE NOTED. IT IS ALSO NOTED THAT THE ABILITY OF THE ENTERPRISE STENT TO WITHSTAND POST BALLOON DILATION HAS NOT BEEN ESTABLISHED. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL CONFORMATION AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PLEASE ALSO NOTE THAT THE LITERATURE ARTICLE FOR THE FOLLOWING MFR. REPORTS IS ATTACHED TO (B)(4). REPORT # 1058196-2011-00337 ONLY. PLEASE NOTE THAT THESE ARE THE INITIAL/FINAL REPORTS FOR THESE FILES.
ADDENDUM (B)(4) 2013: WITH VIA LITERATURE SEARCH MALEK ET AL ¿INCOMPLETE STENT APPOSITION IN ENTERPRISE STENT-MEDIATED COILING OF ANEURYSMS: PERSISTENCE OVER TIME AND RISK OF DELAYED ISCHEMIC EVENTS¿ J. NEUROSURG/MARCH 15, WAS NOTED AND REVIEWED. IT IS NOTED THAT IN ADDITION TO THE EVENTS CAPTURED VIA A PREVIOUSLY PUBLISHED ARTICLE (MALEK AT AL MAY 2007 J.NEUROSURG) WITH CONTINUATION OF THE ENROLLMENT THERE WERE REPORTS OF FOUR ADDITIONAL CASES OF INCOMPLETE APPOSITION OF THE ENTERPRISE STENT WITH FOUR IPSILATERAL LESIONS. THE EVENT OF ASYMPTOMATIC INFARCT WAS INDICATED. A 4.5MM * 22 MM ENTERPRISE WAS IMPLANTED IN THE LEFT ICA. TWO DISTINCT FOCI OF ASYMPTOMATIC CEREBRAL INFARCTION FIRST DETECTED ON ROUTINE FOLLOW-UP IMAGING 20 MONTHS AFTER STENT DEPLOYMENT. ON CLOPIDOGREL; ASA HAD BEEN PREVIOUSLY DISCONTINUED. CONCLUSION: AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: MALEK ET AL IN ¿CRESCENT SIGN ON MAGNETIC RESONANCE ANGIOGRAPHY REVEALING INCOMPLETE STENT APPOSITION: CORRELATION WITH DIFFUSION-WEIGHTED CHANGES IN STENT-MEDICATED COIL EMBOLIZATION OF ANEURYSMS¿; DOI: 10.3171/2011.4.JNS102050. A FOLLOW-UP PUBLICATION ¿INCOMPLETE STENT APPOSITION IN ENTERPRISE STENT-MEDIATED COILING OF ANEURYSMS: PERSISTENCE OVER TIME AND RISK OF DELAYED ISCHEMIC EVENTS¿ J. NEUROSURG/MARCH 15, WAS NOTED AND REVIEWED. WITH CONTINUATION OF THE ENROLLMENT THERE WERE REPORTS OF FOUR ADDITIONAL CASES OF INCOMPLETE APPOSITION OF THE ENTERPRISE STENT WITH FOUR IPSILATERAL LESIONS AS WELL AS ADDITIONAL PATIENT/PRODUCT SPECIFIC INFORMATION PERTAINING TO FOUR OF THE PREVIOUS CAPTURED PATIENT PROCEDURES. A 4.5MM X 22 MM ENTERPRISE WAS IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY (ICA) FOR TREATMENT OF A CAVERNOUS ICA ANEURYSM (CASE NO. 8). THE ADVERSE EVENT OF AN ASYMPTOMATIC INFARCT WAS INDICATED. TWO DISTINCT FOCI OF ASYMPTOMATIC CEREBRAL INFARCTION WERE FIRST DETECTED ON ROUTINE FOLLOW-UP IMAGING 20 MONTHS AFTER STENT DEPLOYMENT. THE PATIENT WAS ON CLOPIDOGREL; ASA HAD BEEN PREVIOUSLY DISCONTINUED. A 4.5MM X 22 MM ENTERPRISE (ENF452212/13471800) WAS IMPLANTED IN THE RIGHT INTERNAL CAROTID ARTERY (ICA) FOR TREATMENT OF A RIGHT OPHTHALMIC ICA ANEURYSM. THE EVENT OF TRANSIENT ISCHEMIC ATTACK (TIA) WAS INDICATED. ADDITIONALLY WITH FOLLOW-UP INVESTIGATION IT WAS NOTED THAT A 4.5MM X22MM ENTERPRISE (ENF452212/13471800) DEPLOYED IN THE HUB (OF THE MICROCATHETER) AND ANOTHER ONE WAS USED. 22 MONTHS AFTER THE DEPLOYMENT OF THE ENTERPRISE STENT, THE PATIENT NOTED AN EPISODE OF WAKING FROM SLEEP WITH DIZZINESS AND LEFT ARM AND LEG WEAKNESS THAT COMPLETELY RESOLVED WITHIN 1 HOUR OF WAKING. THE PATIENT WAS ON CLOPIDOGREL; ASA HAD BEEN DISCONTINUED 1 YEAR PRIOR TO THE EPISODE. THE LATEST MRS SCORE WAS 0. THE FIRST PUBLISHED ARTICLE REPORTED INCOMPLETE ENTERPRISE STENT APPOSITION ASSOCIATED WITH PERI-PROCEDURAL IPSILATERAL LESIONS POST TREATMENT OF UNRUPTURED ANEURYSMS. A DISTINCTIVE SEMILUNAR SIGNAL PATTERN, IDENTIFIED USING 3-T MR ANGIOGRAPHY, REPRESENTED FLOW OUTSIDE THE CONFINES OF THE ENTERPRISE STENT STRUT. THIS PATTERN, DESIGNATED AS THE CRESCENT SIGN, WAS CONFIRMED TO CORRESPOND TO INCOMPLETE STENT APPOSITION BY USE OF HIGH-RESOLUTION ANGIOGRAPHIC FLAT-PANEL CT SCANNING REVEALING FLOW INGRESS INTO AND EGRESS OUT OF THE ISOLATED LUMINAL WEDGE. THE INCOMPLETE STENT APPOSITION WAS ALSO ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL HYPERINTENSE LESIONS ON DIFFUSION WEIGHTED IMAGING. THESE RESULTS IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE PATIENT DID NOT SUFFER ANY IRREVERSIBLE CLINICAL DEFICIT ATTRIBUTED TO THE LESIONS NOTED ON DIFFUSION-WEIGHTED IMAGING BY THE TIME OF DISCHARGE. THE CRESCENT SIGN WAS STRONGLY PREDICTIVE OF IPSILATERAL POSTPROCEDURAL LESIONS SEEN ON DIFFUSION-WEIGHTED IMAGING IN THE ENTIRE POPULATION INCOMPLETE STENT APPOSITION IS DETECTABLE ON 3-T MR ANGIOGRAPHY AS A CRESCENT SIGN, AND WAS FOUND TO BE HIGHLY PREVALENT IN ENTERPRISE CLOSED-CELL DESIGN STENTS USED TO ASSIST COIL EMBOLIZATION OF ANEURYSMS. THE RESULTS OF THE STUDY IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. IT WAS STATED THAT THE INITIAL REPORTS ON INCOMPLETE APPOSITION DEMONSTRATED THAT THE CRESCENT SIGN CAN BE LOCATED ON EITHER THE INNER OR OUTER CURVE OF THE STENT CONTAINING ARTERY. VESSELS WITH LARGER DIAMETERS AND MORE TORTUOUS ANATOMY ARE MORE PRONE TO CAUSE CENTRAL CRIMPING AND LOSS OF STENT LUMINAL DIAMETER THAT LEADS TO INCOMPLETE STENT APPOSITION AND THE APPEARANCE OF THE CRESCENT SIGN ON MRA. IT IS REPORTED THAT EVALUATION OF THE CLINICAL IMPLICATION OF THE CRESCENT SIGN REVEALED THAT IT WS SIGNIFICANTLY RELATED TO AN INCREASE RISK OF PROCEDURAL ISCHEMIC LESIONS DETECTED ON DIFFUSION-WEIGHTED 3-T MRI. THE RESULTS OF THE PREVIOUSLY PUBLISHED ARTICLE IN 2007 WAS LIMITED TO PERIPROCEDURAL PERIOD AND HYPOTHESIZED THAT POOR STENT APPOSITION AS SHOWN BY THE CRESCENT SIGN WOULD BE A RISK FACTOR OR DELAYED ISCHEMIC EVENTS OCCURRING AFTER HOSPITAL DISCHARGE OR SEEN ON SUBSEQUENT IMAGING, SYMPTOMATIC OR ASYMPTOMATIC. THE LATEST ARTICLE EVALUATES THAT HYPOTHESIS BY FOLLOWING THE NATURAL HISTORY OF THE COHORT OF PATIENTS WITH ANALYSIS OF THEIR SUBSEQUENT CLINICAL AND RADIOGRAPHIC TIME COURSE. IT WAS SITED THAT RECENT DATA FROM THE ICES REGISTRY DEMONSTRATED A CORRELATION BETWEEN THE TIMING OF CESSATION OF DOUBLE ANTIPLATELET THERAPY AND DELAYED ISCHEMIC EVENTS, HIGHLIGHTING THE IMPORTANCE OF CONTINUING AN ANTIPLATELET REGIMEN IN CERTAIN CASES. THERE WAS NO SIGNIFICANT RELATIONSHIP BETWEEN PERIPROCEDURAL STROKES AND THE PRESENCE OF A CRESCENT SIGN ON POSTOPERATIVE IMAGING, BUT WERE ASSOCIATED WITH DEVELOPMENT OF DELAYED ISCHEMIC EVENT. 86% OF THE PATIENTS TREATED IN THE SERIES REMAINED ASYMPTOMATIC (MRS SCORE 0), 6% HAD AN MRS SCORE OF 1, 6% AN MRS SCORE OF 2, AND 2% AN MRS SCORE OF 4. ALTHOUGH THERE WAS NO SIGNIFICANT ASSOCIATION BETWEEN FINAL CLINICAL OUTCOME AND THE PRESENCE OF A CRESCENT SIGN, PRESENTING WITH SAH WAS A SIGNIFICANT PREDICTOR OF POOR CLINICAL OUTCOME. PERMANENT INFARCTS OCCURRED IN SIGNIFICANTLY MORE PATIENTS WITH A CRESCENT SIGN THAN WITHOUT EXPERIENCED A PERMANENT INFARCT, A FINDING REPRODUCABLE WITH EXCLUSION OF THOSE PRESENTING WITH SAH. DELAYED ISCHEMIC EVENTS OCCURRED IN 36% OF PATIENTS WITH INCOMPLETE STENT APPOSITION WHEREAS THERE WERE NONE IN THOSE WITHOUT INCOMPLETE STENT APPOSITION. BOTH ASYMPTOMATIC INFARCTS AND SYMPTOMATIC INFARCTS WERE INCLUDED IN THE ANALYSIS. WHILE 6 OF 8 PATIENTS WITH DELAYED ISCHEMIC EVENTS WERE SYMPTOMATIC, THERE WAS ONLY A SINGLE PATIENT WITH A PERMANENT NEUROLOGICAL DEFICIT (2%). A TOTAL OF 3 PERMANENT INFARCTS (6%) OCCURRED IN A DELAYED FASHION. THE STENT REMAINS IMPLANTED AND THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. STENT MALPOSITION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. STROKE IS A KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE ENTERPRISE VRD IS INTENDED FOR USE WITH EMBOLIC COILS FOR THE TREATMENT OF WIDE-NECK, INTRACRANIAL, SACCULAR OR FUSIFORM ANEURYSMS ARISING FROM A PARENT VESSEL WITH A DIAMETER OF ¿ 2.5MM AND ¿ 4MM. THE IFU OUTLINES THAT IT IS GENERALLY CONTRAINDICATED IN PATIENTS IN WHOM THE ANGIOGRAPHY DEMONSTRATES ANATOMY IS NOT APPROPRIATE FOR ENDOVASCULAR TREATMENT DUE TO SEVERE INTRACRANIAL VESSEL TORTUOSITY. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL CHARACTERISTICS AND PROCEDURAL/PATIENT ISSUES ARE FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MDR #S FROM THE FIRST PUBLISHED ARTICLE INCLUDE: 1058196-2011-00337 THRU 00355 & 00358 & 00359.
AN ARTICLE WAS FOUND DURING A LITERATURE SEARCH: MALEK ET AL IN "CRESCENT SIGN ON MAGNETIC RESONANCE ANGIOGRAPHY REVEALING INCOMPLETE STENT APPOSITION: CORRELATION WITH DIFFUSION-WEIGHTED CHANGES IN STENT-MEDICATED COIL EMBOLIZATION OF ANEURYSMS"; DOI: 10.3171/2011.4.JNS102050. THE ARTICLE REPORTED INCOMPLETE ENTERPRISE STENT APPOSITION ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL LESIONS POST TREATMENT OF UNRUPTURED ANEURYSMS. A DISTINCTIVE SEMILUNAR SIGNAL PATTERN, IDENTIFIED USING 3-T MR ANGIOGRAPHY, REPRESENTED FLOW OUTSIDE THE CONFINES OF THE ENTERPRISE STENT STRUT. THIS PATTERN, DESIGNATED AS THE CRESCENT SIGN, WAS CONFIRMED TO CORRESPOND TO INCOMPLETE STENT APPOSITION BY USE OF HIGH-RESOLUTION ANGIOGRAPHIC FLAT-PANEL CT SCANNING REVEALING FLOW INGRESS INTO AND EGRESS OUT OF THE ISOLATED LUMINAL WEDGE. THE INCOMPLETE STENT APPOSITION WAS ALSO ASSOCIATED WITH PERIPROCEDURAL IPSILATERAL HYPERINTENSE LESIONS ON DIFFUSION WEIGHTED IMAGING. THESE RESULTS IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS. THE PATIENT DID NOT SUFFER ANY IRREVERSIBLE CLINICAL DEFICIT ATTRIBUTED TO THE LESIONS NOTED ON DIFFUSION-WEIGHTED IMAGING BY THE TIME OF DISCHARGE. THE CRESCENT SIGN WAS STRONGLY PREDICTIVE OF IPSILATERAL POSTPROCEDURAL LESIONS SEEN ON DIFFUSION-WEIGHTED IMAGING IN THE ENTIRE POPULATION INCOMPLETE STENT APPOSITION IS DETECTABLE ON 3-T MR ANGIOGRAPHY AS A CRESCENT SIGN, AND WAS FOUND TO BE HIGHLY PREVALENT IN ENTERPRISE CLOSED-CELL DESIGN STENTS USED TO ASSIST COIL EMBOLIZATION OF ANEURYSMS. THE RESULTS OF THE STUDY IDENTIFY AN ASSOCIATION BETWEEN INCOMPLETE STENT APPOSITION AND THROMBOEMBOLIC COMPLICATIONS IN STENT-MEDIATED COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |