HERO GRAFT
Report
- Report Number
- 1063481-2015-00128
- Event Type
- Injury
- Date Received
- July 31, 2015
- Date of Event
- February 8, 2014
- Report Date
- July 16, 2015
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- DSY
- PMA / PMN Number
- K124039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
NOTE: THIS MDR IS BEING RE-SENT TO MARK AS INITIAL. THE MFG RECORDS FOR HERO 1001, LOT 001184 AND HERO 1002, LOT 0001186 WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECS PER THE DEVICE MASTER RECORD. THROMBOSIS IS THE MOST COMMON CAUSE OF VASCULAR ACCESS DYSFUNCTION AND IS LISTED AS A POTENTIAL COMPLICATION IN THE HERO INSTRUCTIONS FOR USE (IFU). EIGHT THROMBOSIS EVENTS (IN THE ENTIRE PT POPULATION) WERE DOCUMENTED IN 7 PTS. FOUR OF THE EVENTS WERE TREATED WITH THROMBECTOMY (MECHANICAL AND OPEN) AND GRAFT REVISION; TWO EVENTS WERE TREATED WITH THROMBECTOMY (MECHANICAL AND OPEN) ALONE. A THROMBECTOMY WAS AN APPROPRIATE COURSE OF ACTION TO RESTORE FLOW; HOWEVER, THE HERO IFU STATES THAT MECHANICAL ROTATIONAL DEVICES ARE CONTRAINDICATED IN THE VENOUS OUTFLOW COMPONENT (VOC) AND CONNECTOR AN INTERNAL DAMAGE MAY OCCUR TO THESE COMPONENTS. IT IS UNCLEAR IF THE MECHANICAL THROMBECTOMIES WERE PERFORMED IN THE VOC OR THE ARTERIAL GRAFT COMPONENT (AGC). TWO EVENTS WERE DOCUMENTED AS "NO REINTERVENTION NOTED." PT HISTORY OF MULTIPLE FAILED ACCESSES AND VARIOUS FORMS OF CENTRAL VENOUS STENOSIS MAY HAVE AN IMPACT ON THE RISK OF THROMBOSIS BUT WITHOUT SPECIFIC CASE DETAILS, THE DEGREE OF PT HISTORY INVOLVEMENT IS UNK. HYPERCOAGULABILITY STATES OR INADEQUATELY MAINTAINED ANTICOAGULATION THERAPY COULD CONTRIBUTE TO AN INCREASED RISK OF THROMBOSIS. PRECAUTIONS REGARDING INADEQUATE ANTICOAGULATION ARE PROVIDED IN THE IFU. THE OPERATIVE NOTES FOR HERO IMPLANTS AND THE INTERVENTIONS WERE NOT PROVIDED AND THE SPECIFIC RELATIONSHIP BETWEEN THE HERO GRAFT AND THE OBSERVED THROMBECTOMIES CANNOT BE ASSESSED AT THIS TIME. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNK; HOWEVER, ALL COMPLICATIONS NOTED IN THE COMPLAINT ARE KNOWN POTENTIAL COMPLICATION OF THE HERO GRAFT. THE IFU LISTS THE FOLLOWING POTENTIAL COMPLICATIONS WITH THE USE OF THE HERO GRAFT: SEROMA, INFECTION, VASCULAR GRAFT REVISION/REPLACEMENT, PARTIAL STENOSIS OR FULL OCCLUSION OF PROSTHESIS OR VASCULATURE, PSEUDOANEURYSM, HEMATOMA, AND ABNORMAL HEALING. THE HERO GRAFT IS UNLIKELY TO BE THE DIRECT SOURCE OF THE INFECTION AS THE PRODUCT UNDERGOES A VALIDATED TERMINAL STERILIZATION PROCESS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND THE IFU ADEQUATELY COMMUNICATES RISK.
ACCORDING TO THE PUBLICATION, EXPERIENCE OF HERO DIALYSIS GRAFT PLACEMENT IN A CHALLENGING POPULATION, A TOTAL OF 11 PATIENTS UNDERWENT 12 HERO GRAFT IMPLANTS. ALL OF THE PATIENTS HAD CVOD TO VARYING EXTENTS, INCLUDING SUBCLAVIAN VEIN STENOSIS OR OCCLUSION, INNOMINATE VEIN STENOSIS AND SUPERIOR VENA CAVA STENOSIS. ALL OF THESE PATIENTS HAD MULTIPLE VASCULAR ACCESSES (CATHETERS AND AV FISTULAS OR GRAFTS) PLACED PRIOR TO THE HERO, WITH A MINIMUM OF 2 AND A MAXIMUM OF >14. ONLY 3 PATIENTS HAD A HISTORY OF BACTEREMIA, LEADING TO REMOVAL OF THEIR ACCESS PRIOR TO HERO PLACEMENT. REASONS FOR REINTERVENTION OR FAILURE (N=11): THROMBOSIS (TOTAL OF 5 EVENTS, NUMBER OF FAILED GRAFTS 4), LOCAL INFECTION (TOTAL OF 3 EVENTS, NUMBER OF FAILED GRAFTS 3), PSEUDOANEURYSM (TOTAL OF 2 EVENTS), SEROMA (TOTAL OF 1 EVENT), HEMATOMA (TOTAL OF 1 EVENT) AND NONHEALING INCISION (TOTAL OF 1 EVENT). ASSOCIATED WITH THE LOCAL INFECTION THE PAPER ADDED THE FOLLOWING INFORMATION "GRAFTS REMOVED DUE TO ABCESS FORMATION OVER GRAFT." ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHICH SHOWED THAT PATIENT 2 HAD EXPERIENCED A THROMBOSIS EVENT AFTER THE ORIGINAL PUBLICATION WAS PRINTED. HERO 1001 AND HERO 1002 WERE INVESTIGATED. PATIENT 2 WAS A MALE WHO HAD A HERO GRAFT (HERO 1001, LOT 001184 AND HERO 1002, LOT 0001186) IMPLANTED ON (B)(6) 2010. THE PATIENT HAS HAD MULTIPLE COMPLICATIONS INCLUDING THROMBOSIS, PSEUDOANEURYSM, BACTEREMIA, SEROMA, AND HEMATOMA. BACTEREMIA WAS IDENTIFIED ON (B)(6) 2011 AND THE HERO GRAFT WAS CANNULATED DURING BACTEREMIA. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI HOWEVER, URINE CULTURE RESULTS NO GROWTH. A SECOND BACTEREMIA INCIDENT OCCURRED (B)(6) 2011 AND THE HERO GRAFT WAS NOT CANNULATED DURING. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. A THIRD BACTEREMIA INCIDENT OCCURRED (B)(6) 2011 AND THE HERO GRAFT WAS CANNULATED DURING. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. TWO SEROMAS WERE IDENTIFIED IN THE PATIENT ON (B)(6) 2010 AND (B)(6) 2011; BOTH SEROMAS WERE LOCATED NEAR RIGHT UPPER EXTREMITY NEAR LOCATION OF ARTERIAL ANASTOMOSIS. THREE HEMATOMAS WERE IDENTIFIED ON (B)(6) 2010, (B)(6) 2014 AND (B)(6) 2015. THE HEMATOMAS OCCURRED IN THE RIGHT UPPER EXTREMITY AROUND ARTERIAL END OF GRAFT, IN THE RIGHT UPPER EXTREMITY NEAR ARTERIAL ANASTOMOSIS BUT DID NOT INVOLVE GRAFT, AND IN THE RIGHT UPPER EXTREMITY AROUND DISTAL THIRD OF GRAFT SEGMENT. A MECHANICAL THROMBECTOMY AND REVISION OF THE GRAFT OCCURRED ON (B)(6) 2014 FOR THROMBOSIS. PSEUDOANEURYSMS WERE IDENTIFIED ON (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, DURING ALL THREE OF WHICH THE HERO WAS CANNULATED. EACH EVENT WHICH OCCURRED IN PATIENT 2 WAS INVESTIGATED AND A SEPARATE MEDWATCH FILED. THIS MEDWATCH IS FILED FOR THE MECHANICAL THROMBECTOMY AND REVISION OF THE GRAFT WHICH OCCURRED ON (B)(6) 2014. THE MANUFACTURING RECORDS FOR HERO 1001, LOT 001184 AND HERO 1002, LOT 0001186 WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THROMBOSIS IS THE MOST COMMON CAUSE OF VASCULAR ACCESS DYSFUNCTION AND IS LISTED AS A POTENTIAL COMPLICATION IN THE HERO INSTRUCTIONS FOR USE (IFU). EIGHT THROMBOSIS EVENTS (IN THE ENTIRE PATIENT POPULATION) WERE DOCUMENTED IN 7 PATIENTS. FOUR OF THE EVENTS WERE TREATED WITH THROMBECTOMY (MECHANICAL AND OPEN) AND GRAFT REVISION; TWO EVENTS WERE TREATED WITH THROMBECTOMY (MECHANICAL AND OPEN) ALONE. A THROMBECTOMY WAS AN APPROPRIATE COURSE OF ACTION TO RESTORE FLOW; HOWEVER THE HERO IFU STATES THAT MECHANICAL/ ROTATIONAL DEVICES ARE CONTRAINDICATED IN THE VENOUS OUTFLOW COMPONENT (VOC) AND CONNECTOR AS INTERNAL DAMAGE MAY OCCUR TO THESE COMPONENTS. IT IS UNCLEAR IF THE MECHANICAL THROMBECTOMIES WERE PERFORMED IN THE VOC OR THE ARTERIAL GRAFT COMPONENT (AGC). TWO EVENTS WERE DOCUMENTED AS "NO REINTERVENTION NOTED". PATIENT HISTORY OF MULTIPLE FAILED ACCESSES AND VARIOUS FORMS OF CENTRAL VENOUS STENOSIS MAY HAVE AN IMPACT ON THE RISK OF THROMBOSIS BUT WITHOUT SPECIFIC CASE DETAILS, THE DEGREE OF PATIENT HISTORY INVOLVEMENT IS UNKNOWN. HYPERCOAGULABILITY STATES OR INADEQUATELY MAINTAINED ANTICOAGULATION THERAPY COULD CONTRIBUTE TO AN INCREASED RISK OF THROMBOSIS. PRECAUTIONS REGARDING INADEQUATE ANTICOAGULATION ARE PROVIDED IN THE IFU. THE OPERATIVE NOTES FOR HERO IMPLANTS AND THE INTERVENTIONS WERE NOT PROVIDED AND THE SPECIFIC RELATIONSHIP BETWEEN THE HERO GRAFT AND THE OBSERVED THROMBECTOMIES CANNOT BE ASSESSED AT THIS TIME. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN; HOWEVER, ALL COMPLICATIONS NOTED IN THE COMPLAINT ARE KNOWN POTENTIAL COMPLICATION OF THE HERO GRAFT. THE IFU LISTS THE FOLLOWING POTENTIAL COMPLICATIONS WITH THE USE OF THE HERO GRAFT: SEROMA, INFECTION, VASCULAR GRAFT REVISION/REPLACEMENT, PARTIAL STENOSIS OR FULL OCCLUSION OF PROSTHESIS OR VASCULATURE, PSEUDOANEURYSM, HEMATOMA, AND ABNORMAL HEALING. THE HERO GRAFT IS UNLIKELY TO BE THE DIRECT SOURCE OF THE INFECTION AS THE PRODUCT UNDERGOES A VALIDATED TERMINAL STERILIZATION PROCESS. THERE IS NO INDICATION THAT AN ERROR OR DEFICIENCY OCCURRED AT CRYOLIFE AND THE IFU ADEQUATELY COMMUNICATES RISK.
ACCORDING TO THE PUBLICATION, EXPERIENCE OF HERO DIALYSIS GRAFT PLACEMENT IN A CHALLENGING POPULATION, A TOTAL OF 11 PTS UNDERWENT 12 HERO GRAFT IMPLANTS. ALL OF THE PTS HAD CVOD TO VARYING EXTENTS, INCLUDING SUBCLAVIAN VEIN STENOSIS OR OCCLUSION, INNOMINATE VEIN STENOSIS AND SUPERIOR VENA CAVA STENOSIS. ALL OF THESE PTS HAD MULTIPLE VASCULAR ACCESSES (CATHETERS AND AV FISTULA OR GRAFTS) PLACED PRIOR TO THE HERO, WITH A MINIMUM OF 2 AND A MAXIMUM OF >14. ONLY 3 PTS HAD A HISTORY OF BACTEREMIA, LEADING TO REMOVAL OF THEIR ACCESS PRIOR TO HERO PLACEMENT. REASONS FOR REINTERVENTION OR FAILURE (N=11): THROMBOSIS (TOTAL OF 5 EVENTS, NUMBER OF FAILED GRAFTS 4), LOCAL INFECTION (TOTAL OF 3 EVENTS, NUMBER OF FAILED GRAFTS 3). PSEUDOANEURYSM (TOTAL OF 2 EVENTS), SEROMA (TOTAL OF 1 EVENT), HEMATOMA (TOTAL OF 1 EVENT) AND NONHEALING INCISION (TOTAL OF 1 EVENT). ASSOCIATED WITH THE LOCAL INFECTION THE PAPER ADDED THE FOLLOWING INFO "GRAFTS REMOVED DUE TO ABCESS FORMATION OVER GRAFT." ADD'L INFO WAS RECEIVED FROM THE SURGEON WHICH SHOWED THAT PT 2 HAD EXPERIENCED A THROMBOSIS EVENT AFTER THE ORIGINAL PUBLICATION WAS PRINTED. HERO 1001 AND HERO 1002 WERE INVESTIGATED. PT 2 WAS A MALE WHO HAD A HERO GRAFT (HERO 1001, LOT 001184 AND HERO 1002, LOT 0001186) IMPLANTED ON (B)(6)2010, THE PT HAS HAD MULTIPLE COMPLICATIONS INCLUDING THROMBOSIS, PSEUDOANEURYSM, BACTEREMIA, SEROMA, AND HEMATOMA. BACTEREMIA WAS IDENTIFIED ON (B)(6)2011 AND THE HERO GRAFT WAS CANNULATED DURING BACTEREMIA. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI; HOWEVER, URINE CULTURE RESULTS NO GROWTH. A SECOND BACTEREMIA INCIDENT OCCURRED (B)(6)2011 AND THE HERO GRAFT WAS NOT CANNULATED DURING BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. A THIRD BACTEREMIA INCIDENT OCCURRED (B)(6)2011 AND THE HERO GRAFT WAS CANNULATED DURING BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. TWO SEROMAS WERE IDENTIFIED IN THE PT ON (B)(6)2010 AND (B)(6)2011; BOTH SEROMAS WERE LOCATED NEAR RIGHT UPPER EXTREMITY NEAR LOCATION OF ARTERIAL ANASTOMOSIS. THREE HEMATOMAS WERE IDENTIFIED ON (B)(6)2010, (B)(6)2014 AND (B)(6)2015. THE HEMATOMAS OCCURRED IN THE RIGHT UPPER EXTREMITY AROUND ARTERIAL END OF GRAFT, IN THE RIGHT UPPER EXTREMITY NEAR ARTERIAL ANASTOMOSIS BUT DID NOT INVOLVE GRAFT, AND IN THE RIGHT UPPER EXTREMITY AROUND DISTAL THIRD OF GRAFT SEGMENT. A MECHANICAL THROMBECTOMY AND REVISION OF THE GRAFT OCCURRED ON (B)(6)2014 FOR THROMBOSIS. PSEUDOANEURYSMS WERE IDENTIFIED ON (B)(6)2014, AND (B)(6)2015, DURING ALL THREE OF WHICH THE HERO WAS CANNULATED EACH EVENT WHICH OCCURRED IN PT 2 WAS INVESTIGATED AND A SEPARATE MEDWATH FILED. THIS MEDWATCH IS FILED FOR THE MECHANICAL THROMBECTOMY AND REVISION OF THE GRAFT WHICH OCCURRED ON (B)(6)2014.
ACCORDING TO THE PUBLICATION, EXPERIENCE OF HERO DIALYSIS GRAFT PLACEMENT IN A CHALLENGING POPULATION, A TOTAL OF 11 PATIENTS UNDERWENT 12 HERO GRAFT IMPLANTS. ALL OF THE PATIENTS HAD CVOD TO VARYING EXTENTS, INCLUDING SUBCLAVIAN VEIN STENOSIS OR OCCLUSION, INNOMINATE VEIN STENOSIS AND SUPERIOR VENA CAVA STENOSIS. ALL OF THESE PATIENTS HAD MULTIPLE VASCULAR ACCESSES (CATHETERS AND AV FISTULAS OR GRAFTS) PLACED PRIOR TO THE HERO, WITH A MINIMUM OF 2 AND A MAXIMUM OF >14. ONLY 3 PATIENTS HAD A HISTORY OF BACTEREMIA, LEADING TO REMOVAL OF THEIR ACCESS PRIOR TO HERO PLACEMENT. REASONS FOR REINTERVENTION OR FAILURE (N=11): THROMBOSIS (TOTAL OF 5 EVENTS, NUMBER OF FAILED GRAFTS 4), LOCAL INFECTION (TOTAL OF 3 EVENTS, NUMBER OF FAILED GRAFTS 3), PSEUDOANEURYSM (TOTAL OF 2 EVENTS), SEROMA (TOTAL OF 1 EVENT), HEMATOMA (TOTAL OF 1 EVENT) AND NONHEALING INCISION (TOTAL OF 1 EVENT). ASSOCIATED WITH THE LOCAL INFECTION THE PAPER ADDED THE FOLLOWING INFORMATION "GRAFTS REMOVED DUE TO ABCESS FORMATION OVER GRAFT." ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON WHICH SHOWED THAT PATIENT 2 HAD EXPERIENCED A THROMBOSIS EVENT AFTER THE ORIGINAL PUBLICATION WAS PRINTED. HERO 1001 AND HERO 1002 WERE INVESTIGATED. PATIENT 2 WAS A MALE WHO HAD A HERO GRAFT (HERO 1001, LOT 001184 AND HERO 1002, LOT 0001186) IMPLANTED ON (B)(6) 2010. THE PATIENT HAS HAD MULTIPLE COMPLICATIONS INCLUDING THROMBOSIS, PSEUDOANEURYSM, BACTEREMIA, SEROMA, AND HEMATOMA. BACTEREMIA WAS IDENTIFIED ON (B)(6) 2011 AND THE HERO GRAFT WAS CANNULATED DURING BACTEREMIA. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI HOWEVER, URINE CULTURE RESULTS NO GROWTH. A SECOND BACTEREMIA INCIDENT OCCURRED (B)(6) 2011 AND THE HERO GRAFT WAS NOT CANNULATED DURING. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. A THIRD BACTEREMIA INCIDENT OCCURRED (B)(6) 2011 AND THE HERO GRAFT WAS CANNULATED DURING. BLOOD CULTURE RESULTS GRAM POSITIVE COCCI. TWO SEROMAS WERE IDENTIFIED IN THE PATIENT ON (B)(6) 2010 AND (B)(6) 2011; BOTH SEROMAS WERE LOCATED NEAR RIGHT UPPER EXTREMITY NEAR LOCATION OF ARTERIAL ANASTOMOSIS. THREE HEMATOMAS WERE IDENTIFIED ON (B)(6) 2010, (B)(6) 2014 AND (B)(6) 2015. THE HEMATOMAS OCCURRED IN THE RIGHT UPPER EXTREMITY AROUND ARTERIAL END OF GRAFT, IN THE RIGHT UPPER EXTREMITY NEAR ARTERIAL ANASTOMOSIS BUT DID NOT INVOLVE GRAFT, AND IN THE RIGHT UPPER EXTREMITY AROUND DISTAL THIRD OF GRAFT SEGMENT. A MECHANICAL THROMBECTOMY AND REVISION OF THE GRAFT OCCURRED ON (B)(6) 2014 FOR THROMBOSIS. PSEUDOANEURYSMS WERE IDENTIFIED ON (B)(6) 2014, (B)(6) 2015, AND (B)(6) 2015, DURING ALL THREE OF WHICH THE HERO WAS CANNULATED. EACH EVENT WHICH OCCURRED IN PATIENT 2 WAS INVESTIGATED AND A SEPARATE MEDWATCH FILED. THIS MEDWATCH IS FILED FOR THE MECHANICAL THROMBECTOMY AND REVISION OF THE GRAFT WHICH OCCURRED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 502431 | HERO GRAFT | VASCULAR GRAFT | DSY | CRYOLIFE, INC. | HERO 1001 | 001184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |