THORAFLEX HYBRID
Report
- Report Number
- 9612515-2024-00042
- Event Type
- Death
- Date Received
- June 14, 2024
- Date of Event
- February 25, 2024
- Report Date
- October 16, 2024
- Manufacturer
- VASCUTEK LTD.
- Product Code
- QSK
- PMA / PMN Number
- P210006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MANUFACTURER NARRATIVE: CLINICAL CODE: 2419 - FUNGAL INFECTION: AS REPORTED IN INTAKE FORM, ABSCESSING INFECTION IN THE MEDIASTINUM AND SEVERE AORTIC VALVE REGURGITATION DUE TO ENDOCARDITIS. 1735 -BACTERIAL INFECTION: AS REPORTED IN INTAKE FORM, ABSCESSING INFECTION IN THE MEDIASTINUM AND SEVERE AORTIC VALVE REGURGITATION DUE TO ENDOCARDITIS. 1884-HEMATOMA: AS REPORTED IN INTAKE FORM, RE-THORACOTOMY FOR EVACUATION OF HEMATOMA 2654 - THROMBOEMBOLISM: THE CT SCAN PERFORMED ON (B)(6) 2024 APPEARED TO DEMONSTRATE SOME THROMBUS FORMATION WITHIN THE STENTED SECTION OF THE DEVICE AND ALSO IN THE DISTAL LSA. THE LATER SCAN, PERFORMED ON (B)(6) 2024 DID NOT DEMONSTRATE THE SAME EXTENT OF THROMBOSIS, WITH ONLY AN IRREGULAR APPEARANCE WITHIN THE DISTAL LSA. 1770 - STROKE/CVA: AS REPORTED IN INTAKE FORM, MIDDLE CEREBRAL ARTERY INFARCT DUE TO MULTIPLE ARTERIAL THROMBI IN THE AORTIC ARCH PROTHESIS AND THORACOABDOMINAL AORTIC PROTHESIS. IMPACT CODE: 1802 - DEATH- PATIENT PASSED AWAY ON (B)(6) 2024, CAUSE OF DEATH WAS ASPHYXIA. DEVICE PROBLEM CODE: 2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM - FULL BATCH REVIEW FROM BASE FABRIC TO FINISHED PRODUCT SHOWED THE GRAFT WAS MANUFACTURED TO SPECIFICATION. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 TREND ANALYSIS: A 5-YEAR REVIEW OF SIMILAR COMPLAINTS THORAFLEX (ALL TYPES) LEAKAGE/ OTHER V THORAFLEX SALES (B)(6) GAVE AN OCCURRENCE RATE OF: - REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > INFECTION) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > HEMATOMA) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > STROKE) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. EVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (OCCLUSION /THROMBOSIS) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4) INCREASING TREND WAS IDENTIFIED ACTION REQUIRED AT THIS TIME. 4111: COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION WAS RECEIVED ON 12 JUN 24: THIS CONFIRMED THE BELOW: DEVICE WAS IMPLANTED ON (B)(6) 2019 AND INFECTION WAS PRESENT ON (B)(6) 2024. GRAFT WAS NOT TWISTED OR KINKED. NO DIFFICULTIES IN ORIGINAL PROCEDURE. NO GRAFT DAMAGE, NO ABNORMAL LEAKAGE. STROKE TYPE WAS MCA INFARCT ON THE LEFT SIDE INVOLVING BASAL GANGLIA AND INSULAR WITH MODERATE REACTIVE SWELLING WITHOUT RELEVANT MASS FURTHER INFORMATION WAS RECEIVED FROM THE SITE ON (B)(6) 2024 HIGHLIGHTING THE CULTURES FOUND IN THE SWABS TAKEN FROM THE INFECTED GRAFT: - REMAINING INFECTED FOREIGN MATERIAL AND TRACHEAL SECRETION FROM (B)(6) 2024 WITH E. COLI ESBL ((B)(6) 2024) - THIS BACTERIUM IS NOT SEEN WITHIN THE TAG CLEANROOMS OR DEVICES ENDOCARDITIS WITH STAPHYLOCOCCUS AUREUS ((B)(6) 2024) - THIS BACTERIUM CAN BE FOUND WITHIN THE TAG CLEANROOMS AND PRODUCT. IT IS NOT A SPORE PRODUCING BACTERIUM AND DOES NOT POSE ANY CHALLENGE TO THE ETO STERILIZATION PROCESS COMPARED TO THE BIOLOGICAL INDICATOR PROCESS MONITORING TOOL. ASPERGILLUS FUMIGATES ((B)(6) 2024) - THIS MOULD IS NOT SEEN WITHIN THE TAG CLEANROOMS OR DEVICES. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED WHICH SHOWED NO ISSUES WITH THE DEVICE DURING MANUFACTURE. 4114 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED. 4112 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY: SCANS WERE RECEIVED AND REVIEWED BY THE GLOBAL CLINICAL CASE PLANNING MANAGER ON (B)(6) 2024 THIS CONCLUDED, THE ONE WEEK POST IMPLANT CT SCAN DEMONSTRATES A SUCCESSFUL IMPLANT OF THE THORAFLEX HYBRID DEVICE, WITH FULL PATENCY OF THE MAIN BORE OF THE DEVICE, ALL BRANCH VESSELS AND SUITABLE DISTAL SEALING. THE NEXT CT SCAN REVIEWED WAS PERFORMED AFTER THE REINTERVENTION TO PERFORM ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM AND MECHANICAL AORTIC VALVE REPLACEMENT ((B)(6) 2024). THE CT SCAN PERFORMED ON (B)(6) 2024 APPEARED TO DEMONSTRATE SOME THROMBUS FORMATION WITHIN THE STENTED SECTION OF THE DEVICE AND ALSO IN THE DISTAL LSA. THE LATER SCAN, PERFORMED ON (B)(6) 2024 DID NOT DEMONSTRATE THE SAME EXTENT OF THROMBOSIS, WITH ONLY AN IRREGULAR APPEARANCE WITHIN THE DISTAL LSA. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - THE RELATIONSHIP BETWEEN THE ADVERSE EVENTS (INFECTION, HAEMATOMA AND STROKE) AND THE DEVICE CANNOT BE DETERMINED FROM THE IMAGING. THE DEVICE HAS BEEN IMPLANTED AS INTENDED AND REMAINS PATENT WITH AN EFFECTIVE DISTAL SEAL, WITH NO DEVICE DEFICIENCIES EVIDENT. INVESTIGATION CONCLUSION: 4315 - -CAUSE NOT ESTABLISHED - NO CAUSAL LINK BETWEEN THE DEVICE AND THE EVET COULD BE DETERMINED. ADDITIONAL INFORMATION SECTION A2 ADDED PATIENTS AGE. SECTION G1 UPDATED NAME OF DIRECTOR OF QUALITY. SECTION H7 REMEDIAL ACTION 5369 - RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. 5370 - RE-THORACOTOMY FOR EVACUATION OF HEMATOMA 5373- PATIENT PRESCRIBED ANTIPLATELET MEDICATION, ASPRIN-(ASS). THIS REPORT COVERS 3 EVENTS THAT OCCURRED IN THE SAME PATENT.
THIS SUPPLEMENTAL MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON HUMAN ERROR OCCURRED IN SUBMISSION OF MDRS AS VMSR ( VOLUNTARY MALFUNCTION SUMMARY REPORTING) INSTEAD OF INDIVIDUAL REPORTING REQUIREMENT TO THE FDA. ON 12TH JULY 2024 VASCUTEK WERE CONTACTED BY THE FDA AND INFORMED THAT THE H1 SECTION HAD BEEN INCORRECTLY FILLED IN INITIAL MDR SUBMISSIONS. THE FIRM OPENED A NON-CONFORMANCE - NCR10893 TO MITIGATE QUALITY SYSTEM MANAGEMENT TO ADDRESS ISSUE, EMPLOYEE TRAINING, AND IMPLEMENT CORRECTIVE ACTIONS. NCR10893 WAS OPENED ON 29 AUG 24 AND CLOSED ON 27 SEP 24 . THERE IS NO CHANGE TO THE DEVICE PERFORMANCE OR RISK PROFILE. MANUFACTURER NARRATIVE: CLINICAL CODE: 2419 - FUNGAL INFECTION: AS REPORTED IN INTAKE FORM, ABSCESSING INFECTION IN THE MEDIASTINUM AND SEVERE AORTIC VALVE REGURGITATION DUE TO ENDOCARDITIS. 1735 -BACTERIAL INFECTION: AS REPORTED IN INTAKE FORM, ABSCESSING INFECTION IN THE MEDIASTINUM AND SEVERE AORTIC VALVE REGURGITATION DUE TO ENDOCARDITIS. 1884-HEMATOMA: AS REPORTED IN INTAKE FORM, RE-THORACOTOMY FOR EVACUATION OF HEMATOMA 2654 - THROMBOEMBOLISM: THE CT SCAN PERFORMED ON (B)(6) 2024 APPEARED TO DEMONSTRATE SOME THROMBUS FORMATION WITHIN THE STENTED SECTION OF THE DEVICE AND ALSO IN THE DISTAL LSA. THE LATER SCAN, PERFORMED ON (B)(6) 2024 DID NOT DEMONSTRATE THE SAME EXTENT OF THROMBOSIS, WITH ONLY AN IRREGULAR APPEARANCE WITHIN THE DISTAL LSA. 1770 - STROKE/CVA: AS REPORTED IN INTAKE FORM, MIDDLE CEREBRAL ARTERY INFARCT DUE TO MULTIPLE ARTERIAL THROMBI IN THE AORTIC ARCH PROTHESIS AND THORACOABDOMINAL AORTIC PROTHESIS. IMPACT CODE: 1802 - DEATH- PATIENT PASSED AWAY ON (B)(6) 2024, CAUSE OF DEATH WAS ASPHYXIA. DEVICE PROBLEM CODE: 2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM - FULL BATCH REVIEW FROM BASE FABRIC TO FINISHED PRODUCT SHOWED THE GRAFT WAS MANUFACTURED TO SPECIFICATION. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 TREND ANALYSIS: A 5-YEAR REVIEW OF SIMILAR COMPLAINTS THORAFLEX (ALL TYPES) LEAKAGE/ OTHER V THORAFLEX SALES (B)(6) GAVE AN OCCURRENCE RATE OF: - REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > INFECTION) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > HEMATOMA) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > STROKE) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (OCCLUSION /THROMBOSIS) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4) INCREASING TREND WAS IDENTIFIED ACTION REQUIRED AT THIS TIME. 4111 COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION WAS RECEIVED ON 12 JUN 24: THIS CONFIRMED THE BELOW: DEVICE WAS IMPLANTED ON (B)(6) 2024 AND INFECTION WAS PRESENT ON (B)(6) 2024 GRAFT WAS NOT TWISTED OR KINKED NO DIFFICULTIES IN ORIGINAL PROCEDURE NO GRAFT DAMAGE, NO ABNORMAL LEAKAGE STROKE TYPE WAS MCA INFARCT ON THE LEFT SIDE INVOLVING BASAL GANGLIA AND INSULAR WITH MODERATE REACTIVE SWELLING WITHOUT RELEVANT MASS. FURTHER INFORMATION WAS RECEIVED FROM THE SITE ON 13 JUN 24 HIGHLIGHTING THE CULTURES FOUND IN THE SWABS TAKEN FROM THE INFECTED GRAFT: - REMAINING INFECTED FOREIGN MATERIAL AND TRACHEAL SECRETION FROM (B)(6) 2024 WITH E. COLI ESBL ((B)(6) 2024) - THIS BACTERIUM IS NOT SEEN WITHIN THE TAG CLEANROOMS OR DEVICES ENDOCARDITIS WITH STAPHYLOCOCCUS AUREUS ((B)(6) 2024) - THIS BACTERIUM CAN BE FOUND WITHIN THE TAG CLEANROOMS AND PRODUCT. IT IS NOT A SPORE PRODUCING BACTERIUM AND DOES NOT POSE ANY CHALLENGE TO THE ETO STERILIZATION PROCESS COMPARED TO THE BIOLOGICAL INDICATOR PROCESS MONITORING TOOL. ASPERGILLUS FUMIGATES (BAL (B)(6) 2024) - THIS MOULD IS NOT SEEN WITHIN THE TAG CLEANROOMS OR DEVICES. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED WHICH SHOWED NO ISSUES WITH THE DEVICE DURING MANUFACTURE 4114 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED 4112 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY: SCANS WERE RECEIVED AND REVIEWED BY THE GLOBAL CLINICAL CASE PLANNING MANAGER ON (B)(6) 2024 THIS CONCLUDED, THE ONE WEEK POST IMPLANT CT SCAN DEMONSTRATES A SUCCESSFUL IMPLANT OF THE THORAFLEX HYBRID DEVICE, WITH FULL PATENCY OF THE MAIN BORE OF THE DEVICE, ALL BRANCH VESSELS AND SUITABLE DISTAL SEALING. THE NEXT CT SCAN REVIEWED WAS PERFORMED AFTER THE REINTERVENTION TO PERFORM ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM AND MECHANICAL AORTIC VALVE REPLACEMENT ((B)(6) 2024). THE CT SCAN PERFORMED ON (B)(6) 2024 APPEARED TO DEMONSTRATE SOME THROMBUS FORMATION WITHIN THE STENTED SECTION OF THE DEVICE AND ALSO IN THE DISTAL LSA. THE LATER SCAN, PERFORMED ON (B)(6) 2024 DID NOT DEMONSTRATE THE SAME EXTENT OF THROMBOSIS, WITH ONLY AN IRREGULAR APPEARANCE WITHIN THE DISTAL LSA. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - THE RELATIONSHIP BETWEEN THE ADVERSE EVENTS (INFECTION, HAEMATOMA AND STROKE) AND THE DEVICE CANNOT BE DETERMINED FROM THE IMAGING. THE DEVICE HAS BEEN IMPLANTED AS INTENDED AND REMAINS PATENT WITH AN EFFECTIVE DISTAL SEAL, WITH NO DEVICE DEFICIENCIES EVIDENT. INVESTIGATION CONCLUSION: 4315 - -CAUSE NOT ESTABLISHED - NO CAUSAL LINK BETWEEN THE DEVICE AND THE EVENT COULD BE DETERMINED. ADDITIONAL INFORMATION SECTION A2 ADDED PATIENTS AGE. SECTION G1 UPDATED NAME OF DIRECTOR OF QUALITY. SECTION H7 REMEDIAL ACTION 5369 - RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. 5370 - RE-THORACOTOMY FOR EVACUATION OF HEMATOMA 5373- PATIENT PRESCRIBED ANTIPLATELET MEDICATION, ASPRIN-(ASS). THIS REPORT COVERS 3 EVENTS THAT OCCURRED IN THE SAME PATENT.
MANUFACTURER NARRATIVE: CLINICAL CODE: 2419 - INFECTION CAUSED BY FUNGUS. 1735 - AN ACUTE INFECTIOUS DISORDER CAUSED BY GRAM POSITIVE OR GRAM-NEGATIVE BACTERIA. 1884_ HEMATOMA A LOCALIZED COLLECTION OF BLOOD, USUALLY CLOTTED, IN AN ORGAN, SPACE, OR TISSUE, DUE TO A BREAK IN THE WALL OF A BLOOD VESSEL. 2654 - THROMBUS - OCCLUSION OF THE LUMEN OF A VESSEL BY A THROMBUS THAT HAS MIGRATED FROM A DISTAL SITE VIA THE BLOOD STREAM. 1770 - STROKE A SUDDEN LOSS OF NEUROLOGICAL FUNCTION SECONDARY TO HEMORRHAGE OR ISCHEMIA IN THE BRAIN PARENCHYMA DUE TO A VASCULAR EVENT. IMPACT CODE: 1802 - DEATH- THE CESSATION OF LIFE. DEVICE PROBLEM CODE: 3190 - INSUFFICIENT INFORMATION. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: A 5-YEAR REVIEW OF SIMILAR COMPLAINTS THORAFLEX (ALL TYPES) LEAKAGE/ OTHER V THORAFLEX SALES JAN 20 - 24 GAVE AN OCCURRENCE RATE OF: - REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > INFECTION) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > HEMATOMA) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > STROKE) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (OCCLUSION /THROMBOSIS) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED WHICH SHOWED NO ISSUES WITH THE DEVICE DURING MANUFACTURE. 4114 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED. INVESTIGATION FINDINGS: 3233 - RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSION: D11 - CONCLUSION NOT YET AVAILABLE AS INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION. SECTION H7 REMEDIAL ACTION. 5369 - RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. 5370 - RE-THORACOTOMY FOR EVACUATION OF HEMATOMA. 5373- PATIENT PRESCRIBED ANTIPLATELET MEDICATION, ASPRIN-(ASS).
MANUFACTURER NARRATIVE: CLINICAL CODE: 2419 - FUNGAL INFECTION: AS REPORTED IN INTAKE FORM, ABSCESSING INFECTION IN THE MEDIASTINUM AND SEVERE AORTIC VALVE REGURGITATION DUE TO ENDOCARDITIS. 1735 -BACTERIAL INFECTION: AS REPORTED IN INTAKE FORM, ABSCESSING INFECTION IN THE MEDIASTINUM AND SEVERE AORTIC VALVE REGURGITATION DUE TO ENDOCARDITIS. 1884-HEMATOMA: AS REPORTED IN INTAKE FORM, RE-THORACOTOMY FOR EVACUATION OF HEMATOMA 2654 - THROMBOEMBOLISM: THE CT SCAN PERFORMED ON (B)(6) 2024 APPEARED TO DEMONSTRATE SOME THROMBUS FORMATION WITHIN THE STENTED SECTION OF THE DEVICE AND ALSO IN THE DISTAL LSA. THE LATER SCAN, PERFORMED ON (B)(6) 2024 DID NOT DEMONSTRATE THE SAME EXTENT OF THROMBOSIS, WITH ONLY AN IRREGULAR APPEARANCE WITHIN THE DISTAL LSA. 1770 - STROKE/CVA: AS REPORTED IN INTAKE FORM, MIDDLE CEREBRAL ARTERY INFARCT DUE TO MULTIPLE ARTERIAL THROMBI IN THE AORTIC ARCH PROTHESIS AND THORACOABDOMINAL AORTIC PROTHESIS. IMPACT CODE: 1802 - DEATH- PATIENT PASSED AWAY ON (B)(6) 2024, CAUSE OF DEATH WAS ASPHYXIA. DEVICE PROBLEM CODE : 2993 - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM - FULL BATCH REVIEW FROM BASE FABRIC TO FINISHED PRODUCT SHOWED THE GRAFT WAS MANUFACTURED TO SPECIFICATION. COMPONENT CODE: 4755 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. TYPE OF INVESTIGATION: 4110 - TREND ANALYSIS: A 5-YEAR REVIEW OF SIMILAR COMPLAINTS THORAFLEX (ALL TYPES) LEAKAGE/ OTHER V THORAFLEX SALES (B)(6) GAVE AN OCCURRENCE RATE OF: - · REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > INFECTION) CONFIRMS A FREQUENCY OF OCCURRENCE OF(B)(4). NO ACTION REQUIRED AT THIS TIME. · REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > HEMATOMA) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. · REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (MEDICAL EVENT > STROKE) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4). NO ACTION REQUIRED AT THIS TIME. · REVIEW OF HISTORICAL COMPLAINTS FOR THE SAME DEFECT (OCCLUSION /THROMBOSIS) CONFIRMS A FREQUENCY OF OCCURRENCE OF (B)(4) INCREASING TREND WAS IDENTIFIED ACTION REQUIRED AT THIS TIME. 4111 - COMMUNICATION INTERVIEW: ADDITIONAL INFORMATION WAS RECEIVED ON 12 JUN 24: THIS CONFIRMED THE BELOW: · DEVICE WAS IMPLANTED ON (B)(6) 2019 AND INFECTION WAS PRESENT ON (B)(6) 2024. · GRAFT WAS NOT TWISTED OR KINKED. · NO DIFFICULTIES IN ORIGINAL PROCEDURE. · NO GRAFT DAMAGE, NO ABNORMAL LEAKAGE. · STROKE TYPE WAS MCA INFARCT ON THE LEFT SIDE INVOLVING BASAL GANGLIA AND INSULAR WITH MODERATE REACTIVE SWELLING WITHOUT RELEVANT MASS. [?] FURTHER INFORMATION WAS RECEIVED FROM THE SITE ON (B)(6) 2024 HIGHLIGHTING THE CULTURES FOUND IN THE SWABS TAKEN FROM THE INFECTED GRAFT: - · REMAINING INFECTED FOREIGN MATERIAL AND TRACHEAL SECRETION FROM (B)(6) 2024 WITH E. COLI ESBL ((B)(6).2024) - THIS BACTERIUM IS NOT SEEN WITHIN THE TAG CLEANROOMS OR DEVICES · ENDOCARDITIS WITH STAPHYLOCOCCUS AUREUS ((B)(6) 2024) - THIS BACTERIUM CAN BE FOUND WITHIN THE TAG CLEANROOMS AND PRODUCT. IT IS NOT A SPORE PRODUCING BACTERIUM AND DOES NOT POSE ANY CHALLENGE TO THE ETO STERILIZATION PROCESS COMPARED TO THE BIOLOGICAL INDICATOR PROCESS MONITORING TOOL. · ASPERGILLUS FUMIGATES ((B)(6) 2024) - THIS MOULD IS NOT SEEN WITHIN THE TAG CLEANROOMS OR DEVICES. 3331 - ANALYSIS OF PRODUCTION RECORDS: FULL BATCH REVIEW PERFORMED WHICH SHOWED NO ISSUES WITH THE DEVICE DURING MANUFACTURE. 4114 - DEVICE NOT RETURNED: DEVICE REMAINS IMPLANTED. 4112 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY: SCANS WERE RECEIVED AND REVIEWED BY THE GLOBAL CLINICAL CASE PLANNING MANAGER ON (B)(6) 2024 THIS CONCLUDED, THE ONE WEEK POST IMPLANT CT SCAN DEMONSTRATES A SUCCESSFUL IMPLANT OF THE THORAFLEX HYBRID DEVICE, WITH FULL PATENCY OF THE MAIN BORE OF THE DEVICE, ALL BRANCH VESSELS AND SUITABLE DISTAL SEALING. THE NEXT CT SCAN REVIEWED WAS PERFORMED AFTER THE REINTERVENTION TO PERFORM ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM AND MECHANICAL AORTIC VALVE REPLACEMENT ((B)(6) 2024). THE CT SCAN PERFORMED ON (B)(6) 2024 APPEARED TO DEMONSTRATE SOME THROMBUS FORMATION WITHIN THE STENTED SECTION OF THE DEVICE AND ALSO IN THE DISTAL LSA. THE LATER SCAN, PERFORMED ON (B)(6) 2024 DID NOT DEMONSTRATE THE SAME EXTENT OF THROMBOSIS, WITH ONLY AN IRREGULAR APPEARANCE WITHIN THE DISTAL LSA. INVESTIGATION FINDINGS: 213 - NO DEVICE PROBLEM FOUND - THE RELATIONSHIP BETWEEN THE ADVERSE EVENTS (INFECTION, HAEMATOMA AND STROKE) AND THE DEVICE CANNOT BE DETERMINED FROM THE IMAGING. THE DEVICE HAS BEEN IMPLANTED AS INTENDED AND REMAINS PATENT WITH AN EFFECTIVE DISTAL SEAL, WITH NO DEVICE DEFICIENCIES EVIDENT. INVESTIGATION CONCLUSION: 4315 - -CAUSE NOT ESTABLISHED - NO CAUSAL LINK BETWEEN THE DEVICE AND THE EVET COULD BE DETERMINED. ADDITIONAL INFORMATION SECTION A2 ADDED PATIENTS AGE. SECTION G1 UPDATED NAME OF DIRECTOR OF QUALITY. SECTION H7 REMEDIAL ACTION. 5369 - RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. 5370 - RE-THORACOTOMY FOR EVACUATION OF HEMATOMA. 5373- PATIENT PRESCRIBED ANTIPLATELET MEDICATION, ASPRIN-(ASS).
(B)(4) - INFECTION EVENT WAS REPORTED ON (B)(6) 2024 VIA THE THOR CLINICAL STUDY ((B)(4)). THORAFLEX HYBRID DEVICE WAS IMPLANTED ON (B)(6)2019. EVENT OF ABSCESSING INFECTION BEGAN ON (B)(6) 2024. THE PATIENT HAS BEEN PRESCRIBED ANTIPLATELET MEDICATION. RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. FURTHER EVENT OF HEMATOMA REPORTED ON (B)(6) 2024 ASSIGNED THE (B)(4) - A RE-THORACOTOMY WAS PERFORMED FOR EVACUATION OF HEMATOMA. FURTHER EVENT OF STROKE REPORTED ON (B)(6) 2024 ASSIGNED THE (B)(4) - MIDDLE CEREBRAL ARTERY INFARCT DUE TO MULTIPLE ARTERIAL THROMBI IN THE AORTIC ARCH PROTHESIS AND THORACOABDOMINAL AORTIC PROTHESIS ANTICOAGULATION. CURRENTLY PRESCRIBED ANTIPLATELET MEDICATION ASPRIN -(ASS) ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024 CONFIRMING THE PATIENT PASSED AWAY ON (B)(6) 2024. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #2 FOR MFG REPORT NUMBER 9612515-2024-00042 (B)(4) TO PROVIDE FDA RESPONSE INFORMATION.
(B)(4) - INFECTION EVENT WAS REPORTED ON (B)(6) 2024 VIA THE THOR CLINICAL STUDY (B)(4). THORAFLEX HYBRID DEVICE WAS IMPLANTED ON (B)(6) 2019. EVENT OF ABSCESSING INFECTION BEGAN ON (B)(6) 2024. THE PATIENT HAS BEEN PRESCRIBED ANTIPLATELET MEDICATION. RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. FURTHER EVENT OF HEMATOMA REPORTED ON (B)(6) 2024 ASSIGNED THE (B)(4) - A RE-THORACOTOMY WAS PERFORMED FOR EVACUATION OF HEMATOMA. FURTHER EVENT OF STROKE REPORTED ON (B)(6) 2024 ASSIGNED THE (B)(4) - MIDDLE CEREBRAL ARTERY INFARCT DUE TO MULTIPLE ARTERIAL THROMBI IN THE AORTIC ARCH PROTHESIS AND THORACOABDOMINAL AORTIC PROTHESIS ANTICOAGULATION. CURRENTLY PRESCRIBED ANTIPLATELET MEDICATION ASPRIN -(ASS) ADDITIONAL INFORMATION WAS RECEIVED ON 10 JUN 24 CONFIRMING THE PATIENT PASSED AWAY ON (B)(6) 2024. FOLLOW UP#3 SEE NARRATIVE IN SECTION H11.
(B)(4) - INFECTION EVENT WAS REPORTED ON 05 JUN 24 VIA THE THOR CLINICAL STUDY ((B)(4)). THORAFLEX HYBRID DEVICE WAS IMPLANTED ON (B)(6) 2019. EVENT OF ABSCESSING INFECTION BEGAN ON (B)(6) 2024. THE PATIENT HAS BEEN PRESCRIBED ANTIPLATELET MEDICATION. RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. FURTHER EVENT OF HEMATOMA REPORTED ON (B)(6) 2024 ASSIGNED THE (B)(4) - A RE-THORACOTOMY WAS PERFORMED FOR EVACUATION OF HEMATOMA. FURTHER EVENT OF STROKE REPORTED ON (B)(6) 2024 ASSIGNED THE (B)(4) - MIDDLE CEREBRAL ARTERY INFARCT DUE TO MULTIPLE ARTERIAL THROMBI IN THE AORTIC ARCH PROTHESIS AND THORACOABDOMINAL AORTIC PROTHESIS ANTICOAGULATION. CURRENTLY PRESCRIBED ANTIPLATELET MEDICATION ASPRIN -(ASS). ADDITIONAL INFORMATION WAS RECEIVED ON 10 JUN 24 CONFIRMING THE PATIENT PASSED AWAY ON (B)(6) 2024.
(B)(4) - INFECTION EVENT WAS REPORTED ON 05 JUN 2024 VIA THE THOR CLINICAL STUDY (B)(4). THORAFLEX HYBRID DEVICE WAS IMPLANTED ON (B)(6) 2019. EVENT OF ABSCESSING INFECTION BEGAN ON (B)(6) 2024. THE PATIENT HAS BEEN PRESCRIBED ANTIPLATELET MEDICATION. RE-OPERATION WAS CARRIED OUT FOR ABSCESS DRAINAGE AND SURGICAL DEBRIDEMENT OF THE MEDIASTINUM, MECHANICAL AORTIC VALVE REPLACEMENT. FURTHER EVENT OF HEMATOMA REPORTED ON (B)(6) 2024 ASSIGNED THE (B)(4) - A RE-THORACOTOMY WAS PERFORMED FOR EVACUATION OF HEMATOMA. FURTHER EVENT OF STROKE REPORTED ON 1(B)(6) 2024 ASSIGNED THE (B)(4) - MIDDLE CEREBRAL ARTERY INFARCT DUE TO MULTIPLE ARTERIAL THROMBI IN THE AORTIC ARCH PROTHESIS AND THORACOABDOMINAL AORTIC PROTHESIS ANTICOAGULATION. CURRENTLY PRESCRIBED ANTIPLATELET MEDICATION ASPRIN -(ASS) ADDITIONAL INFORMATION WAS RECEIVED ON 10 JUN 24 CONFIRMING THE PATIENT PASSED AWAY ON (B)(6) 2024. THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MFG REPORT NUMBER 9612515-2024-00042 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183815 | THORAFLEX HYBRID | THORAFLEX HYBRID PLEXUS | QSK | VASCUTEK LTD. | 17876169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Death |