ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
Report
- Report Number
- 1058196-2011-00128
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- November 1, 2012
- Report Date
- March 16, 2011
- 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
INFORMATION WAS REPORTED VIA THE (B)(4) THAT DURING A STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH AN ENTERPRISE VRD ASYMPTOMATIC CEREBRAL INFARCTION WAS OBSERVED IN LEFT SIDE FRONTAL /TEMPORAL LOBE CONFIRMED BY MRI. RECOVERY WAS CONFIRMED WITHOUT ANY TREATMENT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER NEUROLOGICAL SYMPTOMS. IT WAS INITIALLY REPORTED THAT THE RELATIONSHIP OF THE EVENT AND THE DEVICE CANNOT BE DETERMINED. ADDITIONAL UPDATED INFORMATION REPORTED THAT THE DAY AFTER THE PROCEDURE MRI REVEALED VRD THROMBOSIS IN THE LEFT TEMPORAL LOBE WITH THE PHYSICIAN REPORTING THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE ENTERPRISE WAS ALSO HIGHLY PROBABLE. THE MODIFIED RANKIN SCALE PRE AND POST PROCEDURE WAS 0. THE ENTERPRISE WAS PLACED USING A PROWLER SELECT PLUS MICROCATHETER WITH A TOTAL 10 COILS PLACED. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THE ENTERPRISE WAS NOT IMPLANTED WITHIN THROMBUS. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE SACCULAR ANEURYSM MEASURE AT THE NECK 4.7MM, AND NECK TO SAC RATION WAS 4.7MM/8.7MM. AND THE VESSEL PROXIMAL DIAMETER WAS 4.1MM AND DISTALLY WAS 4.0MM. THE RECOMMENDED PARENT VESSEL UPPER LIMIT DIAMETER FOR PLACEMENT OF THE ENTERPRISE VRD AS OUTLINED IN THE IFU IS 4.0MM. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. MEDICATIONS GIVEN CONSISTED OF PRE-PROCEDURE ASPIRIN, AND CILOSTAZOL, AND INTRA-PROCEDURE HEPARIN. ADDITIONAL INFORMATION REPORTED THAT THERE IS NO INDICATION OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422126. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), 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. STENT THROMBOSIS AND CEREBRAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM OR WITH THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT FACTORS INCLUDING PARENT VESSEL DIAMETER, PROCEDURAL 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.
LR PACKAGING L/N # 01422126. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422126. 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. THIS PACKAGING LOT CONTAINED 75 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON (B)(6) 2010. 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 WITIN 30 DAYS OF RECEIPT.
SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED TRANSIENT DYSTOPIA OF THE LEFT EYE. ACTION TAKEN WAS RE-ADMINISTRATION OF ASPIRIN. THE EVENT OUTCOME AS OF FIVE MONTHS AFTER ONSET WAS INDICATED AS "RECOVERED WITHOUT SEQUELAE". ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNKNOWN AND TO THE ENTERPRISE WAS ALSO UNKNOWN. THE REPORT FROM CLINICAL STUDY (B)(4) #(B)(6) THAT DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE VRD STENT ((B)(4)) AND 2 DELATPAQ COILS FOR AN UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY, THE PATIENT HAD ASYMPTOMATIC CEREBRAL INFARCTION IN THE LEFT SIDE FRONTAL / TEMPORAL LOBE BY MRI. RECOVERY WAS CONFIRMED WITHOUT ANY TREATMENT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER NEUROLOGICAL SYMPTOMS. THE MODIFIED RANKIN SCALE PRE AND AFTER THE PROCEDURE WAS 0. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. AFTER THE PROCEDURE, MRI REVEALED VRD THROMBOSIS IN LEFT TEMPORAL LOBE. NO ACTION WAS TAKEN. THE EVENT OUTCOME AS OF ONSET WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE ENTERPRISE WAS ALSO HIGHLY PROBABLE. DURING INITIAL ANGIOGRAMS, FLOW WAS SEEN THROUGHOUT THE TARGET SITE, AND THE ENTERPRISE WAS NOT IMPLANTED WITHIN THROMBUS. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL. THERE WERE INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. NO FURTHER INFORMATION WAS AVAILABLE. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE SACCULAR ANEURYSM MEASURE AT THE NECK 4.7 MM, AND NECK TO SAC RATION WAS 4.7 MM/8.7 MM., AND THE VESSEL PROXIMAL DIAMETER WAS 4.1 MM AND DISTALLY WAS 4.0 MM. A PROWLER SELECT PLUS (CATALOG/LOT# UNK) WAS UTILIZED WITH THE ENTERPRISE SYSTEM, ALSO UTILIZED DURING THE PROCEDURE A GUIDE CATHETER 6FRENCH ROAD MASTER, GUIDEWIRE GT WIRE, AN EXCELSIOR SL- 10 MICROCATHETER, DELTA PAQ (QTY:2) COILS, AND ED COILS (QTY:8). MEDICATIONS GIVEN CONSISTED OF PRE-PROCEDURE ASPIRIN, AND CILOSTAZOL, AND INTRA-PROCEDURE HEPARIN. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422126. 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. CEREBRAL INFARCTION, DYSTOPIA, AND VASCULAR STENT THROMBOSIS ARE A KNOWN POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND COILS IN THE INTRACRANIAL ARTERIES AS OUTLINED IN THE INSTRUCTIONS FOR USE AND IS OUTLINED IN THE DELTAPAQ IFU AS A COMPLICATION SPECIFIC TO EMBOLIZATION PROCEDURES MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. FACTORS INCLUDING TARGET LESION CHARACTERISTICS OF THE PREVIOUSLY CLIPPED ANEURYSM, PATIENT HISTORY AND RESPONSIVENESS TO PHARMACOLOGICAL TREATMENT ARE POSSIBLE CONTRIBUTORS TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE DEVICES AND THE EVENT. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE LOCATION OF THIS PATIENT'S TARGET ANEURYSM AND THE IMPLANTATION OF THE DEVICES MAY HAVE ACTED IN CONCERT TO INCREASE THE INTRACRANIAL PRESSURE AND/OR CREATED SWELLING IN THE TISSUE LOCATED ADJACENT TO THE ANEURYSM CONTRIBUTING TO THE REPORTED SYMPTOMS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN. THIS IS 1 OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00128 AND 2954740-2012-00716.
IX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED TRANSIENT DYSOPIA OF THE LEFT EYE. ACTION TAKEN WAS RE-ADMINISTRATION OF ASPIRIN. THE EVENT OUTCOME AS OF FIVE MONTHS AFTER ONSET WAS INDICATED AS "RECOVERED WITHOUT SEQUEALE". ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNKNOWN AND TO THE ENTERPRISE WAS ALSO UNKNOWN. THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00128 AND 2954740-2012-00716.
INFORMATION WAS REPORTED VIA THE (B)(6) ENTERPRISE POST MARKET SURVEILLANCE THAT DURING A STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH AN ENTERPRISE VRD ASYMPTOMATIC CEREBRAL INFARCTION WAS OBSERVED IN LEFT SIDE FRONTAL /TEMPORAL LOBE CONFIRMED BY MRI. RECOVERY WAS CONFIRMED WITHOUT ANY TREATMENT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER NEUROLOGICAL SYMPTOMS. IT WAS REPORTED THAT THE RELATIONSHIP OF THE EVENT AND THE DEVICE CANNOT BE DETERMINED. THE MODIFIED RANKIN SCALE PRE AND POST PROCEDURE WAS 0. THE ENTERPRISE WAS PLACED USING A PROWLER SELECT PLUS MICROCATHETER WITH A TOTAL 10 COILS PLACED. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE SACCULAR ANEURYSM MEASURE AT THE NECK 4.7MM, AND NECK TO SAC RATION WAS 4.7MM/8.7MM. AND THE VESSEL PROXIMAL DIAMETER WAS 4.1MM AND DISTALLY WAS 4.0MM. MEDICATIONS GIVEN CONSISTED OF PRE-PROCEDURE ASPIRIN, AND CILOSTAZOL, AND INTRA-PROCEDURE HEPARIN. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THE STENT REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422126. 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. CEREBRAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM OR WITH THE PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. ALTHOUGH BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE, PATIENT, PROCEDURAL 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.
AFTER THE PROCEDURE, MRI REVEALED VRD THROMBOSIS IN LEFT TEMPORAL LOBE. NO ACTION WAS TAKEN. THE EVENT OUTCOME AS OF ONSET WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE ENTERPRISE WAS ALSO HIGHLY PROBABLE. DURING INITIAL ANGIOGRAMS, FLOW WAS SEEN THROUGHOUT THE TARGET SITE, AND THE ENTERPRISE WAS NOT IMPLANTED WITHIN THROMBUS. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL. THERE WERE INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
A PROWLER SELECT PLUS (CATALOG/LOT# UNK) WAS UTILIZED WITH THE ENTERPRISE SYSTEM, ALSO UTILIZED DURING THE PROCEDURE A GUIDE CATHETER 6FRENCH ROAD MASTER, GUIDEWIRE GT WIRE, AN EXCELSIOR SL- 10 MICROCATHETER, DELTA PAQ (QTY:2) COILS, AND ED COILS (QTY:8). MEDICATIONS GIVEN CONSISTED OF PRE-PROCEDURE ASPIRIN, AND CILOSTAZOL, AND INTRA-PROCEDURE HEPARIN. A CD COPY OF THE PROCEDURE IS NOT AVAILABLE. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
THE REPORT FROM CLINICAL STUDY (B)(4) THAT DURING A COIL EMBOLIZATION PROCEDURE ASSISTED WITH AN ENTERPRISE VRD STENT (ENC452212) FOR AN UNRUPTURED ANEURYSM IN THE POSTERIOR COMMUNICATING ARTERY, THE PATIENT HAD ASYMPTOMATIC CEREBRAL INFARCTION IN THE LEFT SIDE FRONTAL /TEMPORAL LOBE BY MRI. RECOVERY WAS CONFIRMED WITHOUT ANY TREATMENT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER NEUROLOGICAL SYMPTOMS. THE MODIFIED RANKIN SCALE PRE AND AFTER THE PROCEDURE WAS 0. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT, AND THE ENTERPRISE WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT. THERE WERE NO INDICATIONS OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE SACCULAR ANEURYSM MEASURE AT THE NECK 4.7MM, AND NECK TO SAC RATION WAS 4.7MM/8.7MM., AND THE VESSEL PROXIMAL DIAMETER WAS 4.1MM AND DISTALLY WAS 4.0MM.
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 | 01422126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Life Threatening |