AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM
Report
- Report Number
- 3004753364-2015-00021
- Event Type
- Injury
- Date Received
- August 7, 2015
- Date of Event
- July 6, 2015
- Report Date
- September 4, 2015
- Manufacturer
- LOMBARD MEDICAL LTD.
- Product Code
- MIH
- UDI-DI
- 05055715626316
- PMA / PMN Number
- P110032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
DHR REVIEW: A FULL REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE HAS BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; PRODUCT WAS MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECIFICATIONS. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICE HAS NOT MET THE FINAL RELEASE CRITERIA. VIDEO REVIEW: ADDITIONALLY REVIEW OF AN IN PROCESS VIDEO TAKEN AFTER LOADING OF THE MAIN BODY AND PROXIMAL EXTENDER DEVICES WAS REVIEWED. THIS VIDEO ACTS AS A RECORD THAT THE DEVICE MEETS THE INSPECTION REQUIREMENTS FOR A LOADED IMPLANT. THIS VIDEO CONFIRMED THAT THE DEVICES WERE PACKED INTO THE DELIVERY SYSTEMS IN ACCORDANCE TO COMPANY WORK INSTRUCTION 211, INSPECTION OF PACKED SG-HBB AND SG-HPE DEVICES. CASE REVIEW (INCLUDING SIZING SHEET AND SCAN REVIEW WHERE REQUIRED): ORIGINAL EVAR WAS PERFORMED ON (B)(6) 2015. THE PHYSICIAN DESCRIBED A TYPE 4 ENDOLEAK WHICH REMAINED AT COMPLETION OF THE PROCEDURE. THESE TYPES OF ENDOLEAK ARE ANTICIPATED WITHIN 30 DAYS OF SURGERY DUE TO PATIENT HEPARINIZATION AND ARE EXPECTED TO RESOLVE BY THEMSELVES. THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED AND THE PATIENT WAS FOLLOWED UP AS PER STANDARD PROCEDURE. ON ROUTINE FOLLOW UP (3 MONTHS AFTER THE ORIGINAL EVAR), IT WAS IDENTIFIED THAT THE ENDOLEAK PERSISTED AND AFTER ADDITIONAL FOLLOW UP ON 06 JUL 2015, THE DECISION WAS MADE TO RE-INTERVENE. DURING THE INTERVENTION, THE CLINICIAN IDENTIFIED THAT THE PATIENT HAD A TYPE 3 ENDOLEAK FROM THE AORFIX BODY TOP, HOWEVER THIS HAS NOT BEEN CONFIRMED BY LOMBARD MEDICAL. THE ENDOLEAK MAY HAVE OCCURRED DUE TO PATIENT RECEIVING MAINTENANCE DOSE OF WARFARIN WHICH MAY HAVE CONTRIBUTED TO THE ONGOING ENDOLEAK IDENTIFIED. THE TYPE 3 ENDOLEAK WAS RESOLVED BY IMPLANTATION OF AN ENDURANT CUFF. A TYPE 4 ENDOLEAK STILL REMAINS IN THE IPSILATERAL LEG WHICH WILL BE MONITORED ON FOLLOW-UP. LOMBARD MEDICAL HAS REVIEWED THE CT IMAGES FROM THIS CASE AND IT HAS BEEN IDENTIFIED THAT THE VESSEL DIAMETER IS APPROXIMATELY 12MM WIDE. THE MAIN BODY SELECTED FOR THIS CASE WAS 24MM WIDE WHICH IS EXCESSIVELY OVERSIZED. OVERSIZING OF THIS MAGNITUDE WOULD RESULT IN AN INSUFFICIENT SEAL ZONE AND POTENTIAL FOR A TYPE 1A ENDOLEAK AND CREASING OF THE STENT GRAFT THROUGHOUT THE IMPLANT LEADING TO INCREASED RISK OF COMPLICATIONS. TO CONCLUDE, IT IS PROBABLE THAT THE WARFARIN DOSING MAINTENANCE THAT THE PATIENT IS RECEIVING HAS MAINLY CONTRIBUTED TO THE ENDOLEAKS EXPERIENCED. THERE IS NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION. THE STENT GRAFT HAS PERFORMED AS INTENDED. IFU REVIEW: EACH AORFIX AAA STENT GRAFT MUST BE ORDERED IN A SIZE APPROPRIATE TO FIT THE PATIENT'S ANATOMY. PHYSICIANS SHOULD USE ADEQUATE DIAGNOSTIC TECHNIQUES, INCLUDING CT IMAGING, TO EVALUATE FULLY THE INDIVIDUAL NEEDS OF THE PATIENT. THE STENT GRAFT COMPONENTS SHOULD BE OVERSIZED TO BE LARGER THAN THE VESSEL'S INNER DIAMETER; AORTIC COMPONENTS SHOULD BE OVERSIZED APPROXIMATELY 10-30% AND LEG COMPONENTS BY 10-20%. THE RECOMMENDED OVERALL LENGTH OF THE AORFIX STENT GRAFT, INCLUDING ADDITIONAL COMPONENTS, SHOULD EXTEND FROM THE LOWEST RENAL ARTERY TO JUST ABOVE THE INTERNAL ILIAC (HYPOGASTRIC) ARTERY. ALL LENGTHS AND DIAMETERS OF THE STENT GRAFT COMPONENTS THAT MAY BE NEEDED TO COMPLETE THE PROCEDURE SHOULD BE ORDERED BY AND AVAILABLE TO THE PHYSICIAN, ESPECIALLY WHEN THERE IS A HIGH DEGREE OF COMPLEXITY IN THE ANATOMY THAT MAKES PRECISE PLANNING UNCERTAIN. ACCORDING TO THE EXTENT TO WHICH THE SHAPE OF THE TARGET VESSELS IS CHANGED BY THE INSERTION OF STIFF WIRES, THE OVERALL LENGTH OF EACH STENT GRAFT COMPONENT MAY APPEAR TO BE SHORTER OR LONGER WHEN DEPLOYED. USE OF THE IMPLANT IN ILIAC ARTERIES THAT HAVE A DISTAL LANDING ZONE LESS THAN 9MM IN DIAMETER POSES AN INCREASED RISK FOR IMPLANT COMPLICATIONS AND DELIVERY SYSTEM ENTRAPMENT. ENSURE THAT ACCESS VESSELS ARE CAPABLE OF ACCEPTING THE 22 FR AND 20 FR DELIVERY SYSTEMS. PHYSICIANS MAY CONSULT WITH LOMBARD MEDICAL TO ASSIST IN SELECTING APPROPRIATE COMPONENTS OF THE STENT GRAFT, BASED ON THE PHYSICIAN'S ASSESSMENT OF THE PATIENT'S ANATOMICAL MEASUREMENTS. POTENTIAL ADVERSE EVENTS RELATED TO THE PROCEDURE OR IMPLANT MALFUNCTION INCLUDE, BUT ARE NOT LIMITED TO: LOSS OF STENT GRAFT FUNCTION ARISING FROM, FOR EXAMPLE, IMPROPER COMPONENT PLACEMENT OR DEPLOYMENT, COMPONENT MIGRATION, OCCLUSION, INFECTION, LOSS OF INTEGRITY REQUIRING SURGICAL REVISION, PERFORATION AND ENDOLEAK; WARNINGS AND PRECAUTIONS STATE: THE LONG-TERM PERFORMANCE OF THIS IMPLANT HAS NOT BEEN ESTABLISHED. ALL PATIENTS TREATED WITH THIS DEVICE MUST UNDERGO PERIODIC IMAGING TO EVALUATE STENT GRAFT INTEGRITY AND POSITION, ANEURYSM SIZE, AND POTENTIAL ENDOLEAKS AND/OR, OCCLUSION OF VESSELS IN THE TREATMENT AREA. SIGNIFICANT ANEURYSM ENLARGEMENT, A PERSISTENT ENDOLEAK, THE APPEARANCE OF A NEW ENDOLEAK, DEVICE MIGRATION, REDUCED BLOOD FLOW THROUGH THE GRAFT, AND/OR DECREASE IN RENAL FUNCTION DUE TO RENAL ARTERY OCCLUSION SHOULD PROMPT FURTHER INVESTIGATION INTO THE NEED FOR FURTHER PATIENT TREATMENT, INCLUDING ADDITIONAL INTERVENTION OR SURGICAL CONVERSION. ADDITIONAL PATIENT IMAGING FOLLOW-UP SHOULD BE CONSIDERED FOR PATIENTS WITH DEVICES THAT HAVE EFFECTIVENESS ISSUES.' RISK ANALYSIS: THIS EVENT FALLS OUTSIDE OF LOMBARD MEDICAL'S RISK ANALYSIS WHICH MAKES THE ASSUMPTION THAT THE STENT GRAFT SIZING IS APPROPRIATE TO THE PATIENT'S ANATOMY AND DEVICE SIZES ARE SELECTED IN ACCORDANCE WITH LOMBARD MEDICALS INSTRUCTIONS FOR USE. IN THIS CASE, THE MAIN BODY STENT GRAFT SELECTED WAS OVERSIZED BY 100% WHICH IS NOT RECOMMENDED BY LOMBARD MEDICAL. LOMBARD MEDICALS HAZARDS RISK ANALYSIS HAS BEEN REVIEWED AND PERI-OPERATIVE AND POST-OPERATIVE TYPE 3B ENDOLEAK IS LISTED IN IT. NO FURTHER UPDATE IS REQUIRED. IN THIS CASE, THE PATIENT'S STENT GRAFT IS GROSSLY OVERSIZED AND THE PATIENT IS RECEIVING A MAINTENANCE DOSE OF WARFARIN WHICH MAY HAVE CONTRIBUTED TO THE ONGOING ENDOLEAK IDENTIFIED. THE CURRENT EVENT RATE FOR TYPE 3B ENDOLEAK IS WITHIN CLINICAL EXPECTATIONS. CONCLUSIONS: LOMBARD MEDICAL WILL CONTINUE TO TRACK AND TREND THESE TYPE OF EVENTS IN ACCORDANCE TO QUALITY SYSTEM PROCEDURES AND NOW INTENDS TO CLOSE THIS COMPLAINT FILE.
DHR REVIEW: A FULL REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE HAS BEEN CARRIED OUT WITH NO ANOMALIES IDENTIFIED; PRODUCT WAS MANUFACTURED AND RELEASED FOR SALE IN ACCORDANCE WITH SPECIFICATIONS. THERE IS NO INFORMATION TO SUGGEST THAT THE DEVICE HAS NOT MET THE FINAL RELEASE CRITERIA. FURTHER INVESTIGATION IS BEING PERFORMED AND A FOLLOW-UP REPORT SHALL BE FILED UPON ITS CONCLUSION.
(B)(4)
THE ORIGINAL PROCEDURE WAS PERFORMED ON (B)(6) 2015. ON (B)(6) 2015, CT SCANS REVEALED BLOOD FLOW INTO THE ANEURYSM. THE SCAN WAS REPEATED ON (B)(6) 2015 AND THE BLOOD FLOW INTO THE ANEURYSM WAS STILL PRESENT. ON (B)(6) 2015, A RE-INTERVENTION WAS PERFORMED TO RESOLVE THE ENDOLEAK BY PLACING A COMPETITOR'S PROXIMAL EXTENDER ON THE TOP OF THE MAIN BODY. THE ENDOLEAK WAS SUCCESSFULLY RESOLVED AND THE PATIENT WILL BE FOLLOWED UP AS PER STANDARD PROCEDURES. ((B)(4)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 521155 | AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM | MIH | LOMBARD MEDICAL LTD. | SG-HBB-24-96-80-16 | BW51240-1 | 05055715626316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |