HERO GRAFT
Report
- Report Number
- 1063481-2015-00101
- Event Type
- Injury
- Date Received
- June 23, 2015
- Date of Event
- June 3, 2015
- Report Date
- June 16, 2015
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- DSY
- PMA / PMN Number
- K124039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
A SAMPLE REVIEW WAS HELD ON 07/02/2015. WITHIN THE FORMALIN SOLUTION OF THE SPECIMEN CUP, THERE WAS EVIDENCE OF DARK THROMBUS-LIKE MATERIAL THAT MAY HAVE BEEN DISLODGED FROM THE INNER LUMEN OF THE VOC. THIS CLOT OF MATERIAL WAS REMOVED FROM THE SOLUTION AND EXAMINED ALONG WITH THE VOC. THE MATERIAL WAS HARD IN TEXTURE WHEN MANIPULATED WITH TWEEZERS. NO OTHER VISIBLE EVIDENCE OF THROMBUS FORMATION WAS NOTED WITHIN THE INNER LUMEN OF THE VOC. THE RETURNED VOC WAS PRESENT IN TWO PIECES, WITH A SMALL SECTION (APPROXIMATELY 2CM) COMPLETELY CUT FROM THE PROXIMAL END (THE END ATTACHED TO THE AGC - ARTERIAL GRAFT COMPONENT) OF THE REMAINING VOC. ONE SIDE OF THIS SMALL SECTION APPEARED TO HAVE BEEN MORE CLEANLY CUT AND THIS IS LIKELY WHERE IT WAS REMOVED FROM THE AGC CONNECTOR. THE OTHER END OF THE SMALL SECTION WAS FRAYED AND APPEARED TO BE THE END THAT WAS REMOVED FROM THE REMAINING VOC. AT THIS END, THERE ALSO APPEARED TO BE A SMALL CUT-OUT OR SLIVER THAT WAS MADE INTO THE WALL OF THE VOC WHICH CORROBORATES THE ACCOUNT OF WHERE THE EMBOLECTOMY WAS PERFORMED. THE MANUFACTURING RECORDS FOR LOTS 0001928 AND 0001945 WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. THE PATIENT HAS A HISTORY OF CLOTTING AND INFECTION SECONDARY TO CATHETER DIALYSIS ACCESS. A HERO GRAFT WAS IMPLANTED IN 2013 AND TWO UNSPECIFIED INTERVENTIONS WERE REQUIRED IN EARLY (B)(6) 2015. MOST RECENTLY, THE PATIENT REQUIRED HERO GRAFT DE-CLOT. THROMBOSIS IS THE MOST COMMON CAUSE OF VASCULAR ACCESS DYSFUNCTION AND A POTENTIAL COMPLICATION LISTED IN THE HERO INSTRUCTIONS FOR USE (IFU). EVIDENCE OF A DARK THROMBUS-LIKE MATERIAL WAS FOUND IN THE SOLUTION OF THE SPECIMEN CUP UPON SAMPLE REVIEW. THE CLOTTING WAS TREATED WITH A THROMBECTOMY WITH AN EMBOLECTOMY BALLOON AND AN ANGIOJET ON THE VENOUS OUTFLOW COMPONENT (VOC). A THROMBECTOMY WAS AN APPROPRIATE COURSE OF ACTION TO RESTORE FLOW; HOWEVER THE HERO IFU STATES THAT MECHANICAL/ROTATIONAL DEVICES ARE CONTRAINDICATED IN THE VOC AND CONNECTOR. THE GRAFT CLOTTED THE NEXT DAY AND WAS TREATED WITH VOC REPLACEMENT AND STANDARD THROMBECTOMY ON THE ARTERIAL GRAFT COMPONENT (AGC). THROMBECTOMY WITH REVISION WAS AN APPROPRIATE TREATMENT OPTION AS THE THROMBECTOMY ALONE WAS UNSUCCESSFUL. IT IS UNCLEAR FROM THE INFORMATION PROVIDED WHAT INTERVENTIONS WERE PREVIOUSLY PERFORMED ON THE HERO GRAFT; HISTORY OF PREVIOUS FAILED ACCESS AND CLOTTING ISSUES IS KNOWN. THE PREVIOUS HISTORY OF GRAFT THROMBOSIS SUGGESTS A POSSIBLE HYPERCOAGULABILITY STATE WHICH COULD CONTRIBUTE TO AN INCREASED RISK OF THROMBOSIS. PRECAUTIONS REGARDING INADEQUATE ANTICOAGULATION ARE PROVIDED IN THE IFU. DUE TO GAPS IN THE HISTORY, A RELATIONSHIP BETWEEN THE HERO GRAFT AND THE THROMBOSIS EVENTS CANNOT BE ESTABLISHED. DURING THE DE-CLOT PROCEDURE IN MID-JUNE, THE SURGEON NOTED THAT HE BELIEVED THAT "THE VOC HAD PULLED OUT OF THE ATRIUM AND WAS NOW IN THE SUPERIOR VENA CAVA (SVC)". THIS WAS THE ONLY REFERENCE TO POTENTIAL DEVICE MIGRATION. DEVICE MIGRATION IN LISTED IN THE HERO IFU AS A POTENTIAL VASCULAR GRAFT AND CATHETER COMPLICATION. DIRECTIONS ON HOW TO PLACE THE DEVICE ARE PROVIDED IN THE IFU. THE ORIGINAL OPERATIVE NOTES FROM THE HERO GRAFT IMPLANT INDICATE THE VOC POSITIONING WAS CONFIRMED IN THE RIGHT ATRIUM. TWO YEARS TRANSPIRED FROM IMPLANT TO THE CURRENT CLOTTING ISSUES AND THE GAP HISTORY IS NOT AVAILABLE. IT IS UNCLEAR WHAT IMPACT THIS POTENTIAL DEVICE MIGRATION HAD ON THE PATIENT AND WHEN IT MAY HAVE OCCURRED AND WHAT THE SOURCE MAY HAVE BEEN. THE ROOT CAUSE FOR THE REPORTED EVENTS IS UNKNOWN; HOWEVER, ALL COMPLICATIONS NOTED IN THE COMPLAINT ARE KNOWN POTENTIAL COMPLICATIONS OF THE HERO GRAFT. THE IFU LISTS THE FOLLOWING POTENTIAL COMPLICATIONS WITH THE USE OF THE HERO GRAFT: VASCULAR GRAFT REVISION/REPLACEMENT, PARTIAL STENOSIS OR FULL OCCLUSION OF PROSTHESIS OR VASCULATURE, AND DEVICE MIGRATION. 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 NOTIFICATION FORM, ORIGINAL IMPLANTATION TOOK PLACE ON (B)(6) 2013. PATIENT IS OVER 400 POUNDS AND HE HAD JUST RECENTLY BEEN DE-CLOTTED BY DR. (B)(6) USING AN EMBOLECTOMY BALLOON AND ANGIOJET ON (B)(6) 2015 AND CLOTTED THE NEXT DAY. A PICTURE WAS TAKEN OF THE ATRIUM TO CONFIRM PLACEMENT (NOT AVAILABLE) OF THE VENOUS OUTFLOW COMPONENT (VOC) WHICH WAS IN THE HORIZONTAL POSITION LEADING DR. (B)(6) TO BELIEVE THE VOC HAD PULLED OUT OF THE ATRIUM AND WAS NOW IN THE SUPERIOR VENA CAVA. PATIENT HAD PREVIOUS INTERVENTIONS ON (B)(6) 2015. PRIOR INTERVENTIONS WERE NOT INCLUDED IN THE PATIENT'S HISTORY. DR. (B)(6) MADE AN INCISION OVER THE SITE OF THE TITANIUM CONNECTOR, MADE A SMALL CUT IN THE VOC TO INSERT A .035 X 145 AMPLATZ SUPER STIFF WIRE DOWN TO THE IVC. HE THEN CUT THE VOC AND REMOVED THE EXISTING IMPLANT AND PULLED THE REMAINING PIECE OFF OF THE TITANIUM CONNECTOR. HE THEN INSERTED THE 16F AND 20F SHORT DILATOR WITH SHEATH TO INTRODUCE THE NEW VOC WITH LITTLE DIFFICULTY. THE VOC WAS CONFIRMED UNDER FLUOROSCOPY AND THEN BACK FLUSHED WITH HEPARINIZED SALINE AND CLAMPED TO WORK ON THE ARTERIAL COMPONENT. A STANDARD THROMBECTOMY WAS PERFORMED ON THE ATRIAL COMPONENT UNTIL SUFFICIENT ARTERIAL FLOW WAS RESTORED. THE VOC WAS THEN CUT TO LENGTH AND CONNECTED TO THE EXISTING ARTERIAL COMPONENT, CONFIRMED UNDER FLUOROSCOPY AND DOPPLER. THE PATIENT CURRENTLY HAS A THIGH GRAFT AS HE WAS IN ICU FOR THE PAST 4 DAYS. ATTEMPTS TO OBTAIN INFORMATION FROM THE VASCULAR FELLOW AND DR. (B)(6) AT (B)(6) WERE MADE BY CRYOLIFE REPRESENTATIVE (B)(4). ON (B)(6) 2015, THE VASCULAR FELLOW FORWARDED (TEXTED VIA CELL PHONE) TWO IMAGES WHICH WERE SUPPOSED TO SHOW A BEFORE AND AFTER PHOTOS OF WHERE THE VOC WAS BUT THE IMAGES DID NOT COME THROUGH. (B)(4) TEXTED HER BACK ON (B)(6) 2015 IN REGARDS TO NEW PHOTOS AND WHETHER THE PREVIOUS INTERVENTIONS WERE FOR OCCLUSIONS, NO RESPONSE WAS RECEIVED. ON (B)(6) 2015, HE EMAILED DR. (B)(6) ASKING ABOUT THE PREVIOUS INTERVENTIONS, NO RESPONSE WAS RECEIVED. ON (B)(6) 2015, (B)(4) ATTEMPTED TO CALL BOTH THE VASCULAR FELLOW AND DR. (B)(6), NEITHER OF WHICH CALLED HIM BACK. ON (B)(6) 2015, FIELD ASSURANCE MAILED A LETTER TO DR. (B)(6) REQUESTING ADDITIONAL INFORMATION, IF A RESPONSE IS RECEIVED THE INFORMATION WILL BE INVESTIGATED AT THAT TIME. THE FOLLOWING CASE INFORMATION WAS PROVIDED ABOUT THE IMPLANT OF THE HERO GRAFT: "IMPLANT DATE - (B)(6) 2013; IMPLANTING SURGEON - DR. (B)(6); HOSPITAL - (B)(6) MEDICAL CENTER; OTW/CLEAN STICK - ACCESS THROUGH AN OLD CATHETER; TYPE OF ANASTOMOSIS - END TO SIDE; CENTRAL VENOUS ACCESS - YES; ANTIBIOTIC REGIMEN - ANCEF, VANCOMYCIN; PROCEDURE DURATION - 2:45 H/MIN; IMPLANT SIDE - LEFT; LOCATION OF ANASTOMOSIS - BRACHIAL ARTERY; BRIDGING CATHETER LOCATION - LOWER; SIZE OF ARTERY - 4.5. THIS IS DR. (B)(6)'S FIRST HERO IMPLANT AND HE HAS BEEN WORKING WITH THIS PARTICULAR PATIENT FOR SEVERAL MONTHS IN REGARDS TO IMPLANTING A HERO. THE PATIENT IS ON A CATHETER AND CONTINUES TO CLOT AND GET INFECTED AND IS GETTING CLOSER TO A GROIN PERM CATH, WHICH EVERYONE HAS WANTED TO AVOID. DR. (B)(6)'S INITIAL PLAN IS TO REMOVE THE ASH CATHETER FROM THE LEFT SUBCLAVIAN AND EXCHANGE IT FOR A HERO GRAFT WHILE BRIDGING WITH ANOTHER CATHETER IN THE GROIN. DR. (B)(6) WAS ASSISTED BY THE VASCULAR FELLOW. THE EXTERNAL PORTION OF THE CATHETER WAS COVERED WITH A PIECE OF TAGADERM AND CUT SUBCUTANEOUSLY AND A WIRE WAS INSERTED IN THE INTERNAL PORTION OF THE CATHETER. HE USED A .035 STIFF GLIDEWIRE AND ADVANCED IT ALL THE WAY INTO THE IVC. ONCE HE WAS HAPPY WITH THE WIRE PLACEMENT, HE REMOVED THE EXISTING CATHETER AND BEGAN TO DILATE THE VESSELS. ONCE HE GOT TO THE 20F LONG WITH SHEATH HE HAD A LOT OF DIFFICULTY MAKE THE TURN IN THE ANATOMY AND THE GLIDEWIRE CONTINUED TO BUNCH UP SO I SUGGESTED SWITCHING TO A STIFF AMPLATZ WIRE TO MAKE SURE THE DILATORS AND INTRODUCER TRACKED WELL AND WE AVOIDED AND PERFORATION. ONCE WE SWITCHED WIRES, THE DILATOR WORKED BETTER AND HE USED THE 20F LONG SHEATH TO INTRODUCE THE OC. ONCE HE GOT SOME OF THE WAY INTO THE VESSEL, I SUGGESTED PEELING THE SHEATH AWAY TO MAKE IT EASIER TO ADVANCE, WHICH HE DID. HE CONFIRMED FINAL PLACEMENT IN THE RIGHT ATRIUM UNDER FLUORO. ONCE CONFIRMED, HE CUT THE DISTAL TIP OF THE OC AND TUNNELED IT TO THE DGP WHERE HE BACK FLUSHED AND CLAMPED." BOTH HERO 1001 AND HERO 1002 WERE INVESTIGATED AS BEING POSSIBLY INVOLVED IN THIS COMPLAINT. WE THEN MOVED DOWN THE BRACHIAL ARTERY WHERE THE FELLOW DID THE CUT-DOWN FOR THE ARTERIAL CONNECTION. A NICE DIAMETER ARTERY WAS LOCATED AND ISOLATED AND THE ARTERIAL GRAFT COMPONENT WAS TUNNELED DOWN FROM THE DPG, BOTH COMPONENTS WERE CUT TO LENGTH AND CONNECTED, AFTER CONFIRMING PLACEMENT OF THE OC IN THE RIGHT ATRIUM. THE ENTIRE GRAFT WAS THEN RELEASED TO CHECK FOR LEAKS AND THEN BACK FLUSHED AND RE-CLAMPED AT THE DPG. LEAH COMPLETED THE ARTERIAL ANASTOMOSIS AND FINAL PULSE AND DOPPLER WAS USED TO CONFIRM FLOW. AN ASH CATH WAS PLACED IN THE GROIN AS A BRIDGING CATHETER AND THE REMAINING UPPER BODY CATHETER WAS REMOVED AFTER CLOSURE."
ACCORDING TO THE NOTIFICATION FORM, ORIGINAL IMPLANTATION TOOK PLACE ON (B)(6) 2013. PATIENT IS OVER (B)(6) AND HE HAD JUST RECENTLY BEEN DE-CLOTTED BY DR. (B)(6) USING AN EMBOLECTOMY BALLOON AND ANGIOJET ON (B)(6) 2015 AND CLOTTED THE NEXT DAY. A PICTURE WAS TAKEN OF THE ATRIUM TO CONFIRM PLACEMENT (NOT AVAILABLE) OF THE VENOUS OUTFLOW COMPONENT (VOC) WHICH WAS IN THE HORIZONTAL POSITION LEADING DR. (B)(6) TO BELIEVE THE VOC HAD PULLED OUT OF THE ATRIUM AND WAS NOW IN THE SUPERIOR VENA CAVA. PATIENT HAD PREVIOUS INTERVENTIONS ON (B)(6) 2015. PRIOR INTERVENTIONS WERE NOT INCLUDED IN THE PATIENT'S HISTORY. DR. (B)(6) MADE AN INCISION OVER THE SITE OF THE TITANIUM CONNECTOR, MADE A SMALL CUT IN THE VOC TO INSERT A .035 X 145 AMPLATZ SUPER STIFF WIRE DOWN TO THE IVC. HE THEN CUT THE VOC AND REMOVED THE EXISTING IMPLANT AND PULLED THE REMAINING PIECE OFF OF THE TITANIUM CONNECTOR. HE THEN INSERTED THE 16F AND 20F SHORT DILATOR WITH SHEATH TO INTRODUCE THE NEW VOC WITH LITTLE DIFFICULTY. THE VOC WAS CONFIRMED UNDER FLUOROSCOPY AND THEN BACK FLUSHED WITH HEPARINIZED SALINE AND CLAMPED TO WORK ON THE ARTERIAL COMPONENT. A STANDARD THROMBECTOMY WAS PERFORMED ON THE ATRIAL COMPONENT UNTIL SUFFICIENT ARTERIAL FLOW WAS RESTORED. THE VOC WAS THEN CUT TO LENGTH AND CONNECTED TO THE EXISTING ARTERIAL COMPONENT, CONFIRMED UNDER FLUOROSCOPY AND DOPPLER. THE PATIENT CURRENTLY HAS A THIGH GRAFT AS HE WAS IN ICU FOR THE PAST 4 DAYS. ATTEMPTS TO OBTAIN INFORMATION FROM THE VASCULAR FELLOW AND DR. (B)(6) TO (B)(6) WERE MADE BY CRYOLIFE REPRESENTATIVE (B)(4). ON 6/17/2015 THE VASCULAR FELLOW FORWARDED (TEXTED VIA CELL PHONE) TWO IMAGES WHICH WERE SUPPOSED TO SHOW A BEFORE AND AFTER PHOTOS OF WHERE THE VOC WAS BUT THE IMAGES DID NOT COME THROUGH. (B)(4) TEXTED HER BACK ON 06/29/2015 IN REGARDS TO NEW PHOTOS AND WHETHER THE PREVIOUS INTERVENTIONS WERE FOR OCCLUSIONS, NO RESPONSE WAS RECEIVED. ON 7/10/2015 HE EMAILED DR. (B)(6) ASKING ABOUT THE PREVIOUS INTERVENTIONS, NO RESPONSE WAS RECEIVED. ON 7/14/2015 (B)(4) ATTEMPTED TO CALL BOTH THE VASCULAR FELLOW AND DR. (B)(6), NEITHER OF WHICH CALLED HIM BACK. ON 8/12/2015 FIELD ASSURANCE MAILED A LETTER TO DR. (B)(6) REQUESTING ADDITIONAL INFORMATION, IF A RESPONSE IS RECEIVED THE INFORMATION WILL BE INVESTIGATED AT THAT TIME. THE FOLLOWING CASE INFORMATION WAS PROVIDED ABOUT THE IMPLANT OF THE HERO GRAFT: "IMPLANT DATE - (B)(6) 2013; IMPLANTING SURGEON - DR. (B)(6); HOSPITAL - (B)(6) MEDICAL CENTER; OTW/CLEAN STICK - ACCESS THROUGH AN OLD CATHETER; TYPE OF ANASTOMOSIS - END TO SIDE; CENTRAL VENOUS ACCESS - YES; ANTIBIOTIC REGIMEN - ANCEF, VANCOMYCIN; PROCEDURE DURATION - 2:45 H/MIN; IMPLANT SIDE - LEFT; LOCATION OF ANASTOMOSIS - BRACHIAL ARTERY; BRIDGING CATHETER LOCATION - LOWER; SIZE OF ARTERY - 4.5. THIS IS DR. (B)(6)'S FIRST HERO IMPLANT AND HE HAS BEEN WORKING WITH THIS PARTICULAR PATIENT FOR SEVERAL MONTHS IN REGARDS TO IMPLANTING A HERO. THE PATIENT IS ON A CATHETER AND CONTINUES TO CLOT AND GET INFECTED AND IS GETTING CLOSER TO A GROIN PERM CATH, WHICH EVERYONE HAS WANTED TO AVOID. DR. (B)(6)'S INITIAL PLAN IS TO REMOVE THE ASH CATHETER FROM THE LEFT SUBCLAVIAN AND EXCHANGE IT FOR A HERO GRAFT WHILE BRIDGING WITH ANOTHER CATHETER IN THE GROIN. DR. (B)(6) WAS ASSISTED BY THE VASCULAR FELLOW. THE EXTERNAL PORTION OF THE CATHETER WAS COVERED WITH A PIECE OF TAGADERM AND CUT SUBCUTANEOUSLY AND A WIRE WAS INSERTED IN THE INTERNAL PORTION OF THE CATHETER. HE USED A .035 STIFF GLIDEWIRE AND ADVANCED IT ALL THE WAY INTO THE IVC. ONCE HE WAS HAPPY WITH THE WIRE PLACEMENT, HE REMOVED THE EXISTING CATHETER AND BEGAN TO DILATE THE VESSELS. ONCE HE GOT TO THE 20F LONG WITH SHEATH HE HAD A LOT OF DIFFICULTY MAKE THE TURN IN THE ANATOMY AND THE GLIDEWIRE CONTINUED TO BUNCH UP SO I SUGGESTED SWITCHING TO A STIFF AMPLATZ WIRE TO MAKE SURE THE DILATORS AND INTRODUCER TRACKED WELL AND WE AVOIDED AND PERFORATION. ONCE WE SWITCHED WIRES, THE DILATOR WORKED BETTER AND HE USED THE 20F LONG SHEATH TO INTRODUCE THE OC. ONCE HE GOT SOME OF THE WAY INTO THE VESSEL, I SUGGESTED PEELING THE SHEATH AWAY TO MAKE IT EASIER TO ADVANCE, WHICH HE DID. HE CONFIRMED FINAL PLACEMENT IN THE RIGHT ATRIUM UNDER FLUORO. ONCE CONFIRMED, HE CUT THE DISTAL TIP OF THE OC AND TUNNELED IT TO THE DGP WHERE HE BACK FLUSHED AND CLAMPED." BOTH HERO 1001 AND HERO 1002 WERE INVESTIGATED AS BEING POSSIBLY INVOLVED IN THIS COMPLAINT. WE THEN MOVED DOWN THE BRACHIAL ARTERY WHERE THE FELLOW DID THE CUT-DOWN FOR THE ARTERIAL CONNECTION. A NICE DIAMETER ARTERY WAS LOCATED AND ISOLATED AND THE ARTERIAL GRAFT COMPONENT WAS TUNNELED DOWN FROM THE DPG, BOTH COMPONENTS WERE CUT TO LENGTH AND CONNECTED, AFTER CONFIRMING PLACEMENT OF THE OC IN THE RIGHT ATRIUM. THE ENTIRE GRAFT WAS THEN RELEASED TO CHECK FOR LEAKS AND THEN BACK FLUSHED AND RE-CLAMPED AT THE DPG. LEAH COMPLETED THE ARTERIAL ANASTOMOSIS AND FINAL PULSE AND DOPPLER WAS USED TO CONFIRM FLOW. AN ASH CATH WAS PLACED IN THE GROIN AS A BRIDGING CATHETER AND THE REMAINING UPPER BODY CATHETER WAS REMOVED AFTER CLOSURE."
ACCORDING TO THE NOTIFICATION FORM , "ORIGINAL IMPLANTATION TOOK PLACE ON (B)(6) 2013. PATIENT IS OVER 400 POUNDS AND HE HAD JUST RECENTLY BEEN DE-CLOTTED BY DR. (B)(6) USING AN EMBOLECTOMY BALLOON AND ANGIOJET ON (B)(6) 2015 AND CLOTTED THE NEXT DAY. A PICTURE WAS TAKEN OF THE ATRIUM TO CONFIRM PLACEMENT OF THE VENOUS OUTFLOW COMPONENT WHICH WAS IN A HORIZONTAL POSITION LEADING DR. (B)(6) TO BELIEVE THE VOC HAD PULLED OUT OF THE ATRIUM AND WAS NOW IN THE SVC. PATIENT HAD HAD PREVIOUS INTERVENTIONS ON (B)(6) 2015. PRIOR INTERVENTIONS WERE NOT INCLUDED IN THE PATIENT'S HISTORY. DR. (B)(6) MADE AN INCISION OVER THE SITE OF THE TITANIUM CONNECTOR, MADE A SMALL CUT IN THE VOC TO INSERT A .035 X 145 AMPLATZ SUPER STIFF WIRE DOWN TO THE IVC. HE THEN CUT THE VOC AND REMOVED THE EXISTING IMPLANT AND PULLED THE REMAINING PIECE OFF OF THE TITANIUM CONNECTOR. HE THEN INSERTED THE 16F AND 20F SHORT DILATOR WITH SHEATH TO INTRODUCE THE NEW VOC WITH LITTLE DIFFICULTY. THE VOC WAS CONFIRMED UNDER FLUOROSCOPY AND THEN BACK-FLUSHED WITH HEPARINIZED SALINE AND CLAMPED TO WORK ON THE ARTERIAL COMPONENT. A STANDARD THROMBECTOMY WAS PERFORMED ON THE ARTERIAL COMPONENT UNTIL SUFFICIENT ARTERIAL FLOW WAS RESTORED. THE VOC WAS THEN CUT TO LENGTH AND CONNECTED TO THE EXISTING ARTERIAL COMPONENT, CONFIRMED UNDER FLUOROSCOPY AND DOPPLER. THE PATIENT CURRENTLY HAS A THIGH GRAFT AS HE WAS IN ICU FOR THE PAST 4 DAYS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405438 | HERO GRAFT | VASCULAR GRAFT | DSY | CRYOLIFE, INC. | HERO 1001 | 0001928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |