LOTUS INTRODUCER SET
Report
- Report Number
- 3004193842-2016-00006
- Event Type
- Death
- Date Received
- April 4, 2016
- Date of Event
- March 3, 2016
- Report Date
- March 8, 2016
- Manufacturer
- CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL
- Product Code
- DYB
- PMA / PMN Number
- K140338
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
NOT RETURNED TO MANUFACTURER
DEVICE REVIEW COULD NOT CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS NOT RECEIVED FOR REVIEW. A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED AS THE BATCH NUMBER IS UNKNOWN. A SIMILAR COMPLAINT BATCH REVIEW COULD NOT BE PERFORMED AS THE BATCH NUMBER IS NOT KNOWN. FROM THE INFORMATION AVAILABLE, THERE IS NOTHING TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, TWO ROOT CAUSE CLASSIFICATION CODES ARE ASSIGNED TO THIS COMPLAINT, THESE BEING 'ANTICIPATED PROCEDURAL COMPLICATION' (VESSEL DISSECTION) AND 'OPERATIONAL CONTEXT (DIFFICULT TO INSERT). ANTICIPATED PROCEDURAL COMPLICATION IS DEFINED AS WHERE 'THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE INSTRUCTIONS FOR USE, AND OR DEVICE LABELLING' WHILE OPERATIONAL CONTEXT IS DEFINED AS WHERE 'THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE PERFORMANCE WAS LIMITED'. VESSEL DISSECTION IS DOCUMENTED AS A POTENTIAL ADVERSE EFFECT WITHIN THE LOTUS DFU 139816-01 AND IS AN ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE INSTRUCTIONS FOR USE. THE EVENT DESCRIPTION DESCRIBES THAT THE PATIENT HAS SEVERE VASCULAR DISEASE AND STATES THAT 'SIGNIFICANT CALCIFICATION RESISTANCE' WAS OBSERVED WHEN ADVANCING THE LOTUS INTRODUCER SHEATH. IT IS PROBABLE THAT THE SIGNIFICANT CALCIFICATION CONTRIBUTED TO THE VESSEL DISSECTION. THE SPECIFIC CAUSE OF DEATH IS NOT PROVIDED THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF THE PATIENT DEATH WAS DUE TO THE VESSEL DISSECTION. THE COMPLAINT STATES THAT THE VESSEL DISSECTION WAS SUCCESSFULLY TREATED. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE CAUSE OF DEATH HOWEVER AT THIS TIME THIS INFORMATION HAS NOT BEEN RECEIVED. IN THE EVENT THAT FURTHER INFORMATION IS RECEIVED WHICH CLARIFIES THE CAUSE OF DEATH THIS REPORT WILL BE REVISED ACCORDINGLY. BASED ON A REVIEW OF THE FMEAS AND BASED ON THIS COMPLAINT INVESTIGATION, NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH AT THIS TIME. THERE IS NO INDICATION OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. VESSEL DISSECTION AND USE OF THE LOTUS INTRODUCER SET IN INCOMPATIBLE PATIENT WHERE SEVERE CALCIFICATION ARE BOTH CONSIDERED IN MULTIPLE PLACES WITHIN THE RISK DOCUMENTATION AND ARE NOT A NEW OR UNANTICIPATED FAILURE MODE. CREGANNA MEDICAL WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION. DUE TO A PATIENT DEATH BEING REPORTED, MEDICAL CONSULTANT DR (B)(6) WAS CONTACTED TO REQUEST A CLINICAL REVIEW OF THIS COMPLAINT. DR (B)(6) CONCLUDED THAT "THIS IS AN EXPECTED COMPLICATION RELATED TO INSERTION OF A LARGE SHEATH INTO A DISEASED FEMORAL ARTERY". BASED ON THE ABOVE CONCLUSION, NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CREGANNA MEDICAL WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES. DEVICE NOT RETURNED TO MANUFACTURER.
THE THREE MOST LIKELY LOTS IMPACTED BY THIS COMPLAINT ARE: 274091, 282637 AND 269041 AS SUCH AN LHR REVIEW HAS BEEN COMPLETED FOR EACH LOT. DATE OF MANUFACTURER: 282637 (28-MAY-2015), 274091(07-APR-2015), 269041(05-MAR-2015). LOT EXPIRATION DATE: 282637 (30-APR-2017), 274091 (31-MAR-2017), 269041 (2017-02). DEVICE REVIEW COULD NOT CONFIRM THE REPORTED COMPLAINT AS THE DEVICE WAS NOT RECEIVED FOR REVIEW. A REVIEW OF THE MANUFACTURING DOCUMENTATION WAS COMPLETED AND FOUND THAT NO OBSERVATIONS WERE IDENTIFIED WHICH COULD POTENTIALLY CONTRIBUTE TO THE REPORTED EVENT. IT WAS CONFIRMED THAT TRAINING RECORDS FOR ALL OPERATORS WERE UP-TO-DATE THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE REVIEW OF THE ROUTERS AND SUBSEQUENT SUB ASSEMBLY ROUTERS DID NOT HIGHLIGHT ANY ANOMALIES WHICH COULD POTENTIALLY CONTRIBUTE TO THE REPORTED EVENT. A SIMILAR COMPLAINT TREND REVIEW WAS COMPLETED ON 20 DECEMBER 2016. THE REVIEW FOUND THAT NO COMPLAINTS HAD BEEN REPORTED FOR LOTS 282637, 274091 OR 269041 WITH A SIMILAR EVENT DESCRIPTION TO THIS COMPLAINT. FROM THE INFORMATION AVAILABLE, THERE IS NOTHING TO INDICATE THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE/PRODUCT LABEL. BASED ON THE COMPLAINT REVIEW AND THE EVENT DESCRIPTION FOR THIS COMPLAINT, TWO ROOT CAUSE CLASSIFICATION CODES ARE ASSIGNED TO THIS COMPLAINT, THESE BEING 'ANTICIPATED PROCEDURAL COMPLICATION' (VESSEL DISSECTION) AND 'OPERATIONAL CONTEXT (DIFFICULT TO INSERT). PER CSOP0058, ANTICIPATED PROCEDURAL COMPLICATION IS DEFINED AS WHERE 'THE COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE INSTRUCTIONS FOR USE, AND OR DEVICE LABELLING' WHILE OPERATIONAL CONTEXT IS DEFINED AS WHERE [?]THE COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE PERFORMANCE WAS LIMITED'. VESSEL DISSECTION IS DOCUMENTED AS A POTENTIAL ADVERSE EFFECT WITHIN THE LOTUS DFU 139816-01 AND IS AN ANTICIPATED PROCEDURAL COMPLICATION DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS NOTED WITHIN THE INSTRUCTIONS FOR USE. THE EVENT DESCRIPTION DESCRIBES THAT THE PATIENT HAS SEVERE VASCULAR DISEASE AND STATES THAT [?]SIGNIFICANT CALCIFICATION RESISTANCE' WAS OBSERVED WHEN ADVANCING THE LOTUS INTRODUCER SHEATH. IT IS PROBABLE THAT THE SIGNIFICANT CALCIFICATION CONTRIBUTED TO THE VESSEL DISSECTION. THE SPECIFIC CAUSE OF DEATH IS NOT PROVIDED THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF THE PATIENT DEATH WAS DUE TO THE VESSEL DISSECTION. THE COMPLAINT STATES THAT THE VESSEL DISSECTION WAS SUCCESSFULLY TREATED. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE CAUSE OF DEATH HOWEVER AT THIS TIME THIS INFORMATION HAS NOT BEEN RECEIVED. IN THE EVENT THAT FURTHER INFORMATION IS RECEIVED WHICH CLARIFIES THE CAUSE OF DEATH THIS REPORT WILL BE REVISED ACCORDINGLY. BASED ON A REVIEW OF THE FMEAS AND BASED ON THIS COMPLAINT INVESTIGATION NO UPDATES ARE REQUIRED TO THE RISK DOCUMENTATION FOR THE LOTUS INTRODUCER SHEATH AT THIS TIME. THERE IS NO INDICATION OF A POTENTIAL PROCESSING, DESIGN OR USE FAILURE ASSOCIATED WITH THIS COMPLAINT. VESSEL DISSECTION AND USE OF THE LOTUS INTRODUCER SET IN INCOMPATIBLE PATIENT WHERE SEVERE CALCIFICATION ARE BOTH CONSIDERED IN MULTIPLE PLACES WITHIN THE RISK DOCUMENTATION AND ARE NOT A NEW OR UNANTICIPATED FAILURE MODE. WE WILL CONTINUE TO MONITOR OCCURRENCE RATES PER THE RISK DOCUMENTATION DUE TO A PATIENT DEATH BEING REPORTED, MEDICAL CONSULTANT DR (B)(6) WAS CONTACTED TO REQUEST A CLINICAL REVIEW OF THIS COMPLAINT. DR (B)(6) CONCLUDED THAT "THIS IS AN EXPECTED COMPLICATION RELATED TO INSERTION OF A LARGE SHEATH INTO A DISEASED FEMORAL ARTERY". BASED ON THE ABOVE CONCLUSION NO FURTHER ESCALATION OR CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CREGANNA MEDICAL WILL CONTINUE TO MONITOR FOR THESE COMPLAINT TYPES. NOT RETURNED TO MANUFACTURER.
THE PATIENT UNDERGONE TAVI WORKUP AND THE CT DEMONSTRATED SEVERE BUT NOT PROHIBITIVE PERIPHERAL VASCULAR DISEASE. CONSENSUS WAS REACHED AT CARDIAC CONFERENCE FOR A COMBINED PROCEDURE INVOLVING TAVI UNDER THE SPECIAL ACCESS SCHEME CATEGORY A VIA RIGHT FEMORAL ARTERY SURGICAL CUTDOWN BY VASCULAR SURGICAL COLLEAGUES. VIA THE 6FRENCH RIGHT FEMORAL ARTERY SHEATH, A SUPER -STIFF WIRE WAS PLACED IN THE DESCENDING THORACIC AORTA THROUGH A DIAGNOSTIC PIGTAIL CATHETER. THE LARGE LOTUS INTRODUCER SHEATH WAS THEN SLOWLY ADVANCED OVER THE SUPER STIFF WIRE BUT DUE TO SIGNIFICANT CALCIFICATION RESISTANCE WAS MET SOON AFTER THE TRANSITION POINT OF THE SHEATH HAD PASSED INTO THE ARTERIOTOMY SITE. A DECISION WAS MADE TO ATTEMPT TO GRADUALLY DILATE UP THE ILIOFEMORAL VASCULATURE WITH PROGRESSIVELY LARGER DILATORS. HOWEVER, ON REMOVAL OF THE INTRODUCER FROM THE LARGE LOTUS SHEATH, THERE WAS ACTIVE HAEMORRHAGE AROUND THE SHEATH. CONTRAST INJECTION INTO THE LOTUS SHEATH DEMONSTRATED ACTIVE EXTRAVASATION AT THE LEVEL OF THE RIGHT EXTERNAL ILIAC ARTERY AND SO A 14MM ARMADA BALLOON WAS RAPIDLY PASSED OVER THE SUPER STIFF WIRE INTO THE LARGE LOTUS SHEATH AND INFLATED TO 2ATM WITHIN THE RIGHT COMMON ILIAC ARTERY. FURTHER CONTRAST INJECTION INTO THE SHEATH SUGGESTED ADEQUATE OCCLUSION OF FLOW AND THE VASCULAR SURGEONS WERE ON HAND TO PERFORM RAPID EXPLORATION AND SURGICAL REPAIR OF THE RIGHT EXTERNAL ILIAC ARTERY PERFORATION VIA INSERTION OF A DACRON GRAFT. ONCE HAEMOSTASIS WAS ACHIEVED, A PUNCTURE OF THE RIGHT FEMORAL DACRON GRAFT WAS PERFORMED SO THAT A PIGTAIL CATHETER COULD BE ADVANCED TO THE DISTAL AORTA VIA A 5FRENCH SHEATH. ANGIOGRAPHY DEMONSTRATED NO EXTRAVASATION OF CONTRAST BUT EVIDENCE OF A DISSECTION IMMEDIATELY ABOVE THE DACRON GRAFT EXTENDING UP TO THE DISTAL SEGMENT OF THE RIGHT COMMON ILIAC ARTERY. THIS WAS SUCCESSFULLY TREATED WITH INSERTION OF AN 8 X 27MM EXPRESS LD VASCULAR STENT. AT THIS POINT, IT WAS FELT THAT FURTHER ATTEMPTS AT TAVI THROUGH BOTH A NEWLY INSERTED DACRON GRAFT AND VASCULAR STENT WOULD BE TOO HIGH RISK. CALCIFIED AORTIC ANNULUS SEVERELY CALCIFIED ILIOFEMORAL ANATOMY.
THE PATIENT UNDERGONE TAVI WORKUP AND THE CT DEMONSTRATED SEVERE BUT NOT PROHIBITIVE PERIPHERAL VASCULAR DISEASE. CONSENSUS WAS REACHED AT CARDIAC CONFERENCE FOR A COMBINED PROCEDURE INVOLVING TAVI UNDER THE SPECIAL ACCESS SCHEME CATEGORY A VIA RIGHT FEMORAL ARTERY SURGICAL CUTDOWN BY VASCULAR SURGICAL COLLEAGUES. VIA THE 6FRENCH RIGHT FEMORAL ARTERY SHEATH, A SUPER -STIFF WIRE WAS PLACED IN THE DESCENDING THORACIC AORTA THROUGH A DIAGNOSTIC PIGTAIL CATHETER. THE LARGE LOTUS INTRODUCER SHEATH WAS THEN SLOWLY ADVANCED OVER THE SUPER STIFF WIRE BUT DUE TO SIGNIFICANT CALCIFICATION RESISTANCE WAS MET SOON AFTER THE TRANSITION POINT OF THE SHEATH HAD PASSED INTO THE ARTERIOTOMY SITE. A DECISION WAS MADE TO ATTEMPT TO GRADUALLY DILATE UP THE ILIOFEMORAL VASCULATURE WITH PROGRESSIVELY LARGER DILATORS. HOWEVER, ON REMOVAL OF THE INTRODUCER FROM THE LARGE LOTUS SHEATH, THERE WAS ACTIVE HAEMORRHAGE AROUND THE SHEATH. CONTRAST INJECTION INTO THE LOTUS SHEATH DEMONSTRATED ACTIVE EXTRAVASATION AT THE LEVEL OF THE RIGHT EXTERNAL ILIAC ARTERY AND SO A 14MM ARMADA BALLOON WAS RAPIDLY PASSED OVER THE SUPER STIFF WIRE INTO THE LARGE LOTUS SHEATH AND INFLATED TO 2ATM WITHIN THE RIGHT COMMON ILIAC ARTERY. FURTHER CONTRAST INJECTION INTO THE SHEATH SUGGESTED ADEQUATE OCCLUSION OF FLOW AND THE VASCULAR SURGEONS WERE ON HAND TO PERFORM RAPID EXPLORATION AND SURGICAL REPAIR OF THE RIGHT EXTERNAL ILIAC ARTERY PERFORATION VIA INSERTION OF A DACRON GRAFT. ONCE HAEMOSTASIS WAS ACHIEVED, A PUNCTURE OF THE RIGHT FEMORAL DACRON GRAFT WAS PERFORMED SO THAT A PIGTAIL CATHETER COULD BE ADVANCED TO THE DISTAL AORTA VIA A 5FRENCH SHEATH. ANGIOGRAPHY DEMONSTRATED NO EXTRAVASATION OF CONTRAST BUT EVIDENCE OF A DISSECTION IMMEDIATELY ABOVE THE DACRON GRAFT EXTENDING UP TO THE DISTAL SEGMENT OF THE RIGHT COMMON ILIAC ARTERY. THIS WAS SUCCESSFULLY TREATED WITH INSERTION OF AN 8 X 27MM EXPRESS LD VASCULAR STENT. AT THIS POINT, IT WAS FELT THAT FURTHER ATTEMPTS AT TAVI THROUGH BOTH A NEWLY INSERTED DACRON GRAFT AND VASCULAR STENT WOULD BE TOO HIGH RISK. CALCIFIED AORTIC ANNULUS SEVERELY CALCIFIED ILIOFEMORAL ANATOMY.
THE PATIENT UNDERGONE TAVI WORKUP AND THE CT DEMONSTRATED SEVERE BUT NOT PROHIBITIVE PERIPHERAL VASCULAR DISEASE. CONSENSUS WAS REACHED AT CARDIAC CONFERENCE FOR A COMBINED PROCEDURE INVOLVING TAVI UNDER THE SPECIAL ACCESS SCHEME CATEGORY A VIA RIGHT FEMORAL ARTERY SURGICAL CUTDOWN BY VASCULAR SURGICAL COLLEAGUES. VIA THE 6FRENCH RIGHT FEMORAL ARTERY SHEATH, A SUPER -STIFF WIRE WAS PLACED IN THE DESCENDING THORACIC AORTA THROUGH A DIAGNOSTIC PIGTAIL CATHETER. THE LARGE LOTUS INTRODUCER SHEATH WAS THEN SLOWLY ADVANCED OVER THE SUPER STIFF WIRE BUT DUE TO SIGNIFICANT CALCIFICATION RESISTANCE WAS MET SOON AFTER THE TRANSITION POINT OF THE SHEATH HAD PASSED INTO THE ARTERIOTOMY SITE. A DECISION WAS MADE TO ATTEMPT TO GRADUALLY DILATE UP THE ILIOFEMORAL VASCULATURE WITH PROGRESSIVELY LARGER DILATORS. HOWEVER, ON REMOVAL OF THE INTRODUCER FROM THE LARGE LOTUS SHEATH, THERE WAS ACTIVE HAEMORRHAGE AROUND THE SHEATH. CONTRAST INJECTION INTO THE LOTUS SHEATH DEMONSTRATED ACTIVE EXTRAVASATION AT THE LEVEL OF THE RIGHT EXTERNAL ILIAC ARTERY AND SO A 14 MM ARMADA BALLOON WAS RAPIDLY PASSED OVER THE SUPER STIFF WIRE INTO THE LARGE LOTUS SHEATH AND INFLATED TO 2 ATM WITHIN THE RIGHT COMMON ILIAC ARTERY. FURTHER CONTRAST INJECTION INTO THE SHEATH SUGGESTED ADEQUATE OCCLUSION OF FLOW AND THE VASCULAR SURGEONS WERE ON HAND TO PERFORM RAPID EXPLORATION AND SURGICAL REPAIR OF THE RIGHT EXTERNAL ILIAC ARTERY PERFORATION VIA INSERTION OF A DACRON GRAFT. ONCE HAEMOSTASIS WAS ACHIEVED, A PUNCTURE OF THE RIGHT FEMORAL DACRON GRAFT WAS PERFORMED SO THAT A PIGTAIL CATHETER COULD BE ADVANCED TO THE DISTAL AORTA VIA A 5FRENCH SHEATH. ANGIOGRAPHY DEMONSTRATED NO EXTRAVASATION OF CONTRAST BUT EVIDENCE OF A DISSECTION IMMEDIATELY ABOVE THE DACRON GRAFT EXTENDING UP TO THE DISTAL SEGMENT OF THE RIGHT COMMON ILIAC ARTERY. THIS WAS SUCCESSFULLY TREATED WITH INSERTION OF AN 8 X 27 MM EXPRESS LD VASCULAR STENT. AT THIS POINT, IT WAS FELT THAT FURTHER ATTEMPTS AT TAVI THROUGH BOTH A NEWLY INSERTED DACRON GRAFT AND VASCULAR STENT WOULD BE TOO HIGH RISK. CALCIFIED AORTIC ANNULUS SEVERELY CALCIFIED IOFEMORAL ANATOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201517 | LOTUS INTRODUCER SET | CATHETER INTRODUCER | DYB | CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL | NTR20 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death| R |