HERO GRAFT
Report
- Report Number
- 1063481-2015-00075
- Event Type
- Injury
- Date Received
- June 8, 2015
- Date of Event
- March 14, 2012
- Report Date
- June 1, 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
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 CARDIOVASCULAR OCCLUSIVE DISEASE (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 ARTERIOVENOUS [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 RE-INTERVENTION 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), BACTEREMIA (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 ABSCESS FORMATION OVER GRAFT." THIS MEDWATCH REPRESENTS 1 THROMBOSIS WHICH ENDED IN A FAILED GRAFT. BOTH HERO 1001 AND HERO 1002 WERE INVESTIGATED AS IT COULD NOT BE DETERMINED WHICH COMPONENT, IF EITHER CONTRIBUTED TO THE REPORTED EVENT. PATIENT 6 WAS A MALE WHO HAD A HERO GRAFT (HERO 1001, LOT 0001671 AND HERO 1002, LOT 0001651) IMPLANTED ON (B)(6) 2012. THE GRAFT WAS IDENTIFIED AS THROMBOSED ON (B)(6) 2012 AND THE DECISION WAS MADE FOR NO RE-INTERVENTION FOR THE THROMBOSED GRAFT. GRAFT FAILURE NOTED ON (B)(6) 2012. THE MANUFACTURING RECORDS FOR HERO 1001, LOT 0001671 AND HERO 1002, LOT 0001651 WAS 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.
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.
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 FISTULASD 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." THIS MEDWATCH IS BEING SUBMITTED FOR 1 THROMBOSIS EVENT WHICH ENDED IN A FAILED GRAFT.
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 FISTULASD 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." THIS MEDWATCH IS BEING SUBMITTED FOR 1 THROMBOSIS EVENT WHICH ENDED IN A FAILED GRAFT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368689 | HERO GRAFT | VASCULAR GRAFT | DSY | CRYOLIFE, INC. | HERO 1001 | 0001671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |