ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2013-00128
- Event Type
- Injury
- Date Received
- May 8, 2013
- Date of Event
- October 1, 2012
- Report Date
- April 18, 2013
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
THE (B)(6) STUDY REPORTED A TRANSIENT ISCHEMIC ATTACK APPROXIMATELY 20 MONTHS POST ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF A LEFT PARASELLAR ANEURYSM. THE PATIENT DEVELOPED LEFT HEMIANOPSIA. THE EVENT WAS TREATED WITH ADMINISTRATION OF CLOPIDOGREL 25MG/DAY AND THE PATIENT RECOVERED WITHIN 24 HOURS. THE EVENT OUTCOME APPROXIMATELY SIX MONTHS LATER WAS INDICATED AS ¿RESOLVED WITHOUT SEQUELAE¿. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNKNOWN. IT HASN¿T VERIFIED, BUT HE SUGGESTED VRD THROMBOSIS AS THE POSSIBLE CAUSE OF THE EVENT. BECAUSE IT OCCURRED FOLLOWING DISCONTINUATION OF ANTIPLATELET THERAPY AND LONG PERIOD HAD ELAPSED AFTER THE INDEX PROCEDURE. AT INDEX PROCEDURE (B)(6) FEMALE HAD A MEDICAL HISTORY OF PNEUMONIA AND PREVIOUS COIL EMBOLIZATION FOR C2 SEGMENT OF LEFT INTERNAL CAROTID ARTERY ANEURYSM. THE UNRUPTURED SACCULAR LEFT PARASELLAR ANEURYSM NECK WAS 4.0MM, AND THE NECK TO SAC RATIO WAS 4.0MM:7.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.0MM AND DISTALLY WAS 3.0MM. THE ENTERPRISE VRD WAS IMPLANTED USING A PROWLER SELECT PLUS AND 10 NONCODMAN COILS WERE IMPLANTED USING A JAILING TECHNIQUE VIA AN EXCELSIOR SL10. THE RATE OF OCCLUSION OF THE ANEURYSM POST PROCEDURE WAS 97%. THE ACT WAS 121 SECONDS PRE ANTICOAGULATION AND 265 SECONDS POST ANTICOAGULATION. HEPARIN 5000U WAS ADMINISTERED INTRA-PROCEDURALLY. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY BEGINNING 2 DAYS PRE-PROCEDURE FOR 10 MONTHS AND CLOPIDOGREL 75MG/DAY BEGINNING 2 DAYS PRE-PROCEDURE FOR 13 MONTHS AND THEN 25MG/DAY FOR APPROXIMATELY 7 MONTHS. ONGOING CLOPIDOGREL WAS RESTARTED AFTER THE REPORTED TIA. AT FOLLOW-UP APPROXIMATELY 7 AND A HALF MONTHS POST PROCEDURE THE COILED ANEURYSM AND PARENT VESSEL MEASUREMENTS WERE UNCHANGED AND THE OCCLUSION RATE OF THE ANEURYSM WAS 97% THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0 PRE-PROCEDURE PROCEDURE AS WELL AS IMMEDIATELY POST PROCEDURE, THREE MONTHS AND 7.5 MONTHS POST PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AND NO PROCEDURAL IMAGES ARE AVAILABLE. THE ENTERPRISE VRD REMAINS IMPLANTED. (B)(4) DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424846. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(4) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. ISCHEMIA AND NEUROLOGICAL DEFICITS AS WELL AS THROMBOTIC EVENTS ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
CC UPDATED WITH ADDITIONAL INFORMATION - NO FURTHER CHANGES TO AE CODES OR EVALUATION CODES. THE (B)(6) PMS ENTERPRISE STUDY REPORTED A TRANSIENT ISCHEMIC ATTACK APPROXIMATELY 20 MONTHS POST ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF A LEFT PARASELLAR ANEURYSM. IT WAS INITIALLY REPORTED THAT THE PATIENT DEVELOPED LEFT HEMIANOPSIA; HOWEVER, ADDITIONAL INFORMATION REPORTED THAT THE EVENT WAS DIPLOPIA INSTEAD OF LEFT HEMIANOPSIA. THE EVENT WAS TREATED WITH ADMINISTRATION OF CLOPIDOGREL 25MG/DAY AND THE PATIENT RECOVERED WITHIN 24 HOURS. THE EVENT OUTCOME APPROXIMATELY SIX MONTHS LATER WAS INDICATED AS ¿RESOLVED WITHOUT SEQUELAE¿. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNKNOWN. IT HASN¿T VERIFIED, BUT HE SUGGESTED VRD THROMBOSIS AS THE POSSIBLE CAUSE OF THE EVENT. BECAUSE IT OCCURRED FOLLOWING DISCONTINUATION OF ANTIPLATELET THERAPY AND LONG PERIOD HAD ELAPSED AFTER THE INDEX PROCEDURE. AT INDEX PROCEDURE (B)(6) FEMALE HAD A MEDICAL HISTORY OF PNEUMONIA AND PREVIOUS COIL EMBOLIZATION FOR C2 SEGMENT OF LEFT INTERNAL CAROTID ARTERY ANEURYSM. THE UNRUPTURED SACCULAR LEFT PARASELLAR ANEURYSM NECK WAS 4.0MM, AND THE NECK TO SAC RATIO WAS 4.0MM:7.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.0MM AND DISTALLY WAS 3.0MM. THE ENTERPRISE VRD WAS IMPLANTED USING A PROWLER SELECT PLUS AND 10 NONCODMAN COILS WERE IMPLANTED USING A JAILING TECHNIQUE VIA AN EXCELSIOR SL10. THE RATE OF OCCLUSION OF THE ANEURYSM POST PROCEDURE WAS 97%. THE ACT WAS 121 SECONDS PRE ANTICOAGULATION AND 265 SECONDS POST ANTICOAGULATION. HEPARIN 5000U WAS ADMINISTERED INTRA-PROCEDURALLY. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY BEGINNING 2 DAYS PRE-PROCEDURE FOR 10 MONTHS AND CLOPIDOGREL 75MG/DAY BEGINNING 2 DAYS PRE-PROCEDURE FOR 13 MONTHS AND THEN 25MG/DAY FOR APPROXIMATELY 7 MONTHS. ONGOING CLOPIDOGREL WAS RESTARTED AFTER THE REPORTED TIA. AT FOLLOW-UP APPROXIMATELY 7 AND A HALF MONTHS POST PROCEDURE THE COILED ANEURYSM AND PARENT VESSEL MEASUREMENTS WERE UNCHANGED AND THE OCCLUSION RATE OF THE ANEURYSM WAS 97% THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0 PRE-PROCEDURE AS WELL AS IMMEDIATELY POST PROCEDURE, THREE MONTHS AND 7.5 MONTHS POST PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AND NO PROCEDURAL IMAGES ARE AVAILABLE. THE ENTERPRISE VRD REMAINS IMPLANTED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424846. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ISCHEMIA AND NEUROLOGICAL DEFICITS AS WELL AS THROMBOTIC EVENTS ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 4.0MM, AND THE NECK TO SAC RATIO WAS 4.0MM:7.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.0MM AND DISTALLY WAS 3.0MM. MRS ON (B)(6) 2011 WAS 0, ON (B)(6) 2011 WAS 0, AND ON (B)(6) 2011 WAS 0. THE ACT WAS 121 SECONDS PRE ANTICOAGULATION AND 265 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 97% AFTER THE PROCEDURE. THE FOLLOW-UP WAS TOOK PLACE ON (B)(6) 2011, ANEURYSM NECK WAS 4.0MM, AND THE NECK TO SAC RATIO WAS 4.0MM:7.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 4.0MM AND DISTALLY WAS 3.0MM. THE OCCLUSION RATE OF ANEURYSM WAS 97%. MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2011, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011, 25MG/DAY: (B)(6) 2012, HEPARIN 5000U WAS ADMINISTERED INTRA-PROCEDURALLY. PRIOR TO IMPLANTING THE VRD, LAUNCHER 7FR 90CM/MEDTRONIC, PROWLER SELECT PLUS(606-S255X, LOT UNKNOWN), RADIFOCUS GT 180CM 0.012INCH/TERUMO WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10(TYPE J)/STRYKER, GDC10 2D SOFT(4MM X 8CM)/STRYKER, GDC10 2D(3MM X 8CM)/STRYKER, V-TRACK MICROPLEX HYPERSOFT(2MM X 6CM, 3MM X 6CM TOTAL 2, 3MM X 4CM TOTAL 3)/TERUMO, ED COIL(3MM X 6CM, 3MM X 4CM)/KANEKA. DURING THE PROCEDURE, JAILED TECHNIQUE WAS UTILIZED. NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: LAUNCHER 7FR 90CM/MEDTRONIC (DETAILS UNKNOWN); PROWLER SELECT PLUS (606-S255X, LOT UNKNOWN); RADIFOCUS GT 180CM 0.012INCH/TERUMO (DETAILS UNKNOWN); EXCELSIOR SL10(TYPE J)/STRYKER (DETAILS UNKNOWN); GDC10 2D SOFT(4MM X 8CM)/STRYKER (DETAILS UNKNOWN); GDC10 2D(3MM X 8CM)/STRYKER (DETAILS UNKNOWN); V-TRACK MICROPLEX HYPERSOFT(2MM X 6CM, 3MM X 6CM TOTAL 2, 3MM X 4CM TOTAL 3)/TERUMO (DETAILS UNKNOWN); ED COIL(3MM X 6CM, 3MM X 4CM)/KANEKA (DETAILS UNKNOWN). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
(B)(4). TRANSIENT ISCHEMIC ATTACK. THIS COMPLAINT IS FROM A CLINICAL STUDY "(B)(4) PMS ENTERPRISE" #107-04 INDEX PROCEDURE TOOK PLACE ON (B)(6) 2011. THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH VRD (ENC452812/01424846) OF LEFT PARASELLAR. THE FOLLOWING ABOUT 20 MONTHS OF THE INDEX PROCEDURE, AROUND (B)(6) 2012, THE PATIENT DEVELOPED LEFT HEMIANOPSIA. CLOPIDOGREL SULFATE 25MG WAS ADMINISTERED FOR THE TREATMENT AND THE PATIENT RECOVERED WITHIN 24 HOURS. THE EVENT OUTCOME AS OF (B)(6) 2013 WAS INDICATED AS "RESOLVED WITHOUT SEQUEALE." ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNKNOWN. IT HASN'T BEEN VERIFIED, BUT HE SUGGESTED VRD THROMBOSIS AS THE POSSIBLE CAUSE OF THE EVENT BECAUSE IT OCCURRED FOLLOWING DISCONTINUATION OF ANTIPLATELET THERAPY AND A LONG PERIOD HAD ELAPSED AFTER THE INDEX PROCEDURE. THE PATIENT HAD A MEDICAL HISTORY OF PNEUMONIA AND PREVIOUS COIL EMBOLISATION FOR C2 SEGMENT OF LEFT INTERNAL CAROTID ARTERY ANEURYSM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201828 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | 01424846 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |