ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2014-00157
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- May 23, 2014
- Report Date
- May 26, 2014
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10293168. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM LOCATED IN BIFURCATION AT RIGHT VERTEBRAL ARTERY AND POSTERIOR INFERIOR CEREBELLAR ARTERY, THE PHYSICIAN PULLED BACK THE PROWLER SELECT PLUS MICROCATHETER (606-S255X/LOT UNKNOWN) PROXIMALLY TO DEPLOY THE VRD (ENC452200/(B)(4)) FROM RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY TO VERTEBRAL ARTERY ACROSS THE TARGET ANEURYSM, BUT IT WAS NOTED THAT THE DISTAL STENT MARKERS OF THE VRD WERE OVERLAPPED WITH EACH OTHER THROUGH THE ANGIOGRAM. THEN, THE MICROCATHETER WAS MOVED DISTALLY AND RECAPTURED THE VRD SYSTEM. THE VRD WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ONE (ENC452200, LOT UNKNOWN). THE ANEURYSM NECK WAS ENTIRELY COVERED WITH THE REPLACED VRD THAT WAS ADVANCED THROUGH THE SAME MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE UNRUPTURED DISSECTING FUSIFORM ANEURYSM NECK WAS 8.0MM, AND THE NECK TO SAC RATIO WAS 8.0MM:8.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 2.5MM. NO INFORMATION REGARDING MRS, INR, PT AND PTT WAS PROVIDED. ALSO THE OCCLUSION RATE OF THE ANEURYSM AFTER THE PROCEDURE WAS UNKNOWN. ANTIPLATELET THERAPY INCLUDED ASPIRIN AND CLOPIDOGREL SULFATE WERE ADMINISTERED. NO INFORMATION REGARDING THE DOSAGE AND START DATE OF THE ANTIPLATELET THERAPY. THE DEVICES UTILIZED DURING THE PROCEDURE INCLUDES UNSPECIFIED SHEATH INTRODUCER/TERUMO, TRAXCESS/TERUMO, LAUNCHER 7FRENCH (TYPE UNKNOWN)/MEDTRONIC, PROWLER SELECT PLUS( 606-S255X, LOT UNKNOWN), ECHELON 10(TYPE UNKNOWN)/COVIDIEN JAPAN, UNSPECIFIED Y-CONNECTOR/ABBOTT. NO INFORMATION REGARDING THE IMPLANTED COILS WAS PROVIDED. DURING THE PROCEDURE, JAILED TECHNIQUE WAS UTILIZED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC.) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. THE VESSEL WAS NOT CALCIFIED AND MODERATELY TORTUOUS. NO ADDITIONAL INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. A NON-STERILE UNIT OF ENTERPRISE WAS RECEIVED INSIDE OF A PLASTIC BAG, AND THE STENT WAS RECEIVED DEPLOYED. THE DELIVERY WIRE, COIL DISPENSER, TUBE PEEL AND STENT WERE RECEIVED AND NO DAMAGES WERE OBSERVED ON THE DEVICES. GLOVES AND GAUZES WERE OBSERVED IN THE BAG. DELIVERY WIRE AND STENT WERE INSPECTED UNDER VISION SYSTEM; ON DELIVERY WIRE DRIED BLOOD RESIDUALS WERE OBSERVED AND SALINE SOLUTION RESIDUALS, ON THE STENT NO DAMAGES WERE OBSERVED. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10293168. 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. THE CAUSE AND TIMING OF THE STENT OVERLAP NOTED ON THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, SINCE THE RETURNED DEVICE WAS RETURNED WITH THE STENT DEPLOY AND FULLY EXPANDED. THE RETURNED DEVICE DID NOT PRESENT WITH INDICATION OF MANUFACTURING DEFECTS OR ANOMALY CONTRIBUTING TO THE REPORTED EVENT AND THE DEVICE HISTORY RECORDS REVIEW INDICATE THAT THE PRODUCT MET SPECIFICATION PRIOR TO SHIPMENT. IT IS POSSIBLE THAT CLINICAL/PROCEDURAL FACTORS INCLUDING VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED; HOWEVER, BASED ON THE AVAILABLE INFORMATION NO CONCLUSION CAN BE MADE. THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.
THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. PRIOR TO USE, NO DEFECT (KINK, BENDS ETC) WAS NOTED ON THE PRODUCT BY VISUAL INSPECTION. ALSO NO DAMAGES WERE REPORTED ON THE DEVICE AFTER THE EVENT. THE COMPLAINT PRODUCT IS GOING TO BE RETURNED FOR EVALUATION. THE VESSEL WAS NOT CALCIFIED AND MODERATELY TORTUOUS. NO ADDITIONAL INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. CONCOMITANT MEDICAL PRODUCTS: THE DEVICES UTILIZED DURING THE PROCEDURE INCLUDES UNSPECIFIED SHEATH INTRODUCER/TERUMO, TRAXCESS/TERUMO, LAUNCHER 7FR(TYPE UNKNOWN)/MEDTRONIC, PROWLER SELECT PLUS( 606-S255X, LOT UNKNOWN), ECHELON 10(TYPE UNKNOWN)/COVIDIEN (B)(4), UNSPECIFIED Y-CONNECTOR/ABBOTT. THE PRODUCT WILL BE RETURN FOR ANALYSIS, BUT IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANEURYSM LOCATED IN BIFURCATION AT RIGHT VERTEBRAL ARTERY AND POSTERIOR INFERIOR CEREBELLAR ARTERY, THE PHYSICIAN PULLED BACK THE PROWLER SELECT PLUS MICROCATHETER (606-S255X/LOT UNKNOWN) PROXIMALLY TO DEPLOY THE VRD (ENC452200/10293168) FROM RIGHT POSTERIOR INFERIOR CEREBELLAR ARTERY TO VERTEBRAL ARTERY ACROSS THE TARGET ANEURYSM, BUT IT WAS NOTED THAT THE DISTAL STENT MARKERS OF THE VRD WERE OVERLAPPED WITH EACH OTHER THROUGH THE ANGIOGRAM. THEN, THE MICROCATHETER WAS MOVED DISTALLY AND RECAPTURED THE VRD SYSTEM. THE VRD WAS SAFELY REMOVED FROM THE PATIENT AND WAS REPLACED FOR A NEW ONE (ENC452200, LOT UNKNOWN). THE ANEURYSM NECK WAS ENTIRELY COVERED WITH THE REPLACED VRD THAT WAS ADVANCED THROUGH THE SAME MICROCATHETER. AFTERWARDS, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT INJURY/COMPLICATIONS REPORTED. THE UNRUPTURED DISSECTING FUSIFORM ANEURYSM NECK WAS 8.0MM, AND THE NECK TO SAC RATIO WAS 8.0MM: 8.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.5MM AND DISTALLY WAS 2.5MM. NO INFORMATION REGARDING MRS, INR, PT AND PTT WAS PROVIDED. ALSO THE OCCLUSION RATE OF THE ANEURYSM AFTER THE PROCEDURE WAS UNKNOWN. ANTIPLATELET THERAPY INCLUDED ASPIRIN AND CROPIDOGREL SULFATE WERE ADMINISTERED. NO INFORMATION REGARDING THE DOSAGE AND START DATE OF THE ANTIPLATELET THERAPY. THE DEVICES UTILIZED DURING THE PROCEDURE INCLUDES UNSPECIFIED SHEATH INTRODUCER/TERUMO, TRAXCESS/TERUMO, LAUNCHER 7FR(TYPE UNKNOWN)/MEDTRONIC, PROWLER SELECT PLUS (606-S255X, LOT UNKNOWN), ECHELON 10(TYPE UNKNOWN)/COVIDIEN (B)(4), UNSPECIFIED Y-CONNECTOR/ABBOTT. NO INFORMATION REGARDING THE IMPLANTED COILS WERE PROVIDED. DURING THE PROCEDURE, JAILED TECHNIQUE WAS UTILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319571 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | 10293168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |