ATW GUIDEWIRE
Report
- Report Number
- 1016427-2011-00017
- Event Type
- Death
- Date Received
- February 18, 2011
- Date of Event
- January 12, 2011
- Report Date
- January 24, 2011
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DQX
- PMA / PMN Number
- K994358
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE THE ATW WIRE FRACTURED / SEPARATED IN THE PATIENT AND AFTER THE SUBSEQUENT RETRIEVAL PROCEDURE THE PATIENT SUFFERED A STROKE. THIS IS A (B)(6) OLD MALE WITH MEDICAL HISTORY SIGNIFICANT FOR CONGESTIVE HEART FAILURE, SEVERE ISCHEMIC CARDIOMYOPATHY WITH ESTIMATED LEFT VENTRICULAR EJECTION FRACTION OF 15% AND SEVERE MITRAL REGURGITATION. THE INDICATION FOR THE PROCEDURE WAS ACUTE NON-ST ELEVATION MYOCARDIAL INFARCTION. THE TARGET VESSEL WAS THE LEFT CIRCUMFLEX ARTERY WHICH WAS DIFFUSELY ATHEROSCLEROTIC WITH A HIGH GRADE IN THE PROXIMAL VESSEL AND 50% STENOSIS IN THE PROXIMAL PORTION OF A LARGE SECOND OBTUSE MARGINAL BRANCH. A SGW ATW WIRE WAS USED FOR THE PROCEDURE, AND THE LESION WAS PRE-DILATED WITH A MAVERICK BALLOON. THEN A 3.5 X 18MM PROMUS STENT WAS SUCCESSFULLY DEPLOYED IN THE PROXIMAL VESSEL. POST DILATION WAS SUBSEQUENTLY PERFORMED IN THE MID SEGMENT OF THE STENT WITH A 3.5MM HIGH PRESSURE BALLOON BECAUSE OF A MILD INDENTATION IN THAT AREA. EXCELLENT ANGIOGRAPHIC RESULTS WERE REPORTED WITH TIMI GRADE3 FLOW. THE PHYSICIAN ATTEMPTED TO REMOVE THE ATW WIRE; HOWEVER, THERE WAS RESISTANCE TO WITHDRAWAL. SEPARATION OF THE DISTAL TIP WAS NOTED AFTER THE WIRE WAS REMOVED FROM THE PATIENT. THE WIRE HAD BEEN REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END AND DID NOT APPEAR DAMAGED PRIOR TO USE. THE WIRE WAS RE-SHAPED WITH SLIGHT CURVING WITH AN INTRODUCER BY THE PHYSICIAN. THERE HAD BEEN NO DIFFICULTY IN TRACKING THE WIRE THROUGH THE VESSEL OR LESION, AND THE WIRE BEHAVED NORMALLY DURING TORQUE. THE TIP DID NOT PROLAPSE DURING TREATMENT, AND WAS ADVANCED INTO THE DISTAL VASCULATURE. SUBSEQUENT INJECTION STRONGLY SUGGESTED THAT THERE WAS STENT MALFUNCTION WITH FRACTURE AND MILD DISTAL MIGRATION AND 'CRUMPLING' OF THE PROXIMAL SEGMENT. MULTIPLE ATTEMPTS TO REGAIN ACCESS INTO THE DISTAL VESSEL WERE UNSUCCESSFUL. THE FOLLOWING DAY, A REPEAT CATHETERIZATION REVEALED THAT THE CIRCUMFLEX ARTERY HAD EXCELLENT FLOW AND THERE DID NOT APPEAR TO BE ANY ILL-EFFECTS FROM THE STENT MALFUNCTION. THE MAJOR PROBLEM CONTINUED TO BE THE SEVERE MITRAL REGURGITATION IN THE SETTING OF SIGNIFICANT LEFT VENTRICULAR DYSFUNCTION. APPROXIMATELY SIX DAYS LATER, THE PATIENT UNDERWENT MITRAL VALVE REPAIR, CORONARY ARTERY BYPASS GRAFTING OF THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL, AND RETRIEVAL OF THE WIRE TIP IN THE ASCENDING AORTA AND LEFT MAIN CORONARY. THE DECISION TO PERFORM THE SURGERY WAS BASED ON THE SEVERE MITRAL REGURGITATION IN ADDITION TO THE RETAINED WIRE AND WORRY THAT THE CIRCUMFLEX VESSEL MAY OCCLUDE BECAUSE OF THE STENT MALFUNCTION. DURING THE PROCEDURE IT WAS NOTED THAT THE HEART WAS EXTREMELY DILATED AND THE RIGHT HEART WAS POORLY FUNCTIONING. THE EJECTION FRACTION WAS APPROXIMATELY 10 TO 15%. THE HEART BEGAN TO FAIL VERY QUICKLY; HOWEVER, THE CARDIOPULMONARY BYPASS WAS PERFORMED QUICKLY AND THE PATIENT MAINTAINED A GOOD BLOOD PRESSURE THROUGHOUT THIS TIME WITH A MEAN ARTERIAL PRESSURE OF APPROXIMATELY 65. A SMALL TRANSVERSE AORTOTOMY WAS PERFORMED AND A SMALL WIRE WAS SEEN TO BE EMANATING FROM THE LEFT MAIN CORONARY ARTERY. THE WIRE WAS GRABBED WITH FORCEPS AND EASILY REMOVED. THE END OF THE WIRE FROM THE DESCENDING AORTA PULLED OUT EASILY THROUGH THE CROSSCLAMP AND WAS RETRIEVED. THE WIRE WAS NOTED TO BE 15 ½ CM IN LENGTH. THE AORTOTOMY WAS RECLOSED. THE BYPASS GRAFT AND VALVE REPLACEMENT WERE THEN COMPLETED AND THE PATIENT WAS WEANED FROM BYPASS. THE LEFT VENTRICULAR EJECTION FRACTION APPEARED TO BE APPROXIMATELY 15% AND THE RIGHT VENTRICLE APPEARED TO BE POOR AS WELL. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN STABLE CONDITION, BUT EXPERIENCED AND MASSIVE STROKE AND EXPIRED APPROXIMATELY FIVE DAYS LATER. PRODUCT ANALYSIS: A SITE VISIT WAS INITIATED, AS THE ACCOUNT WILL NOT RELEASE THE PRODUCT FOR ANALYSIS. THE GUIDEWIRE WAS IN NON-STERILE CONDITION, STORED IN THE ORIGINAL POUCH, STORED IN THE CATH LAB AREA. ONLY THE PROXIMAL SIDE OF THE FRACTURE WAS AVAILABLE FOR OUR REVIEW. THE DISTAL SIDE OF THE FRACTURE (THE TIP) AND THE DEFORMED PROMUS STENT WERE REPORTED TO BE SALVAGED, BUT THAT EVENT TOOK PLACE IN THE SURGICAL SUITE, AND THE RISK MANAGER DID NOT KNOW WHERE THE GUIDEWIRE TIP AND THE STENT WERE LOCATED. THERE WAS NOTHING NOTABLE ABOUT THE GUIDEWIRE (PTFE SLEEVE AND PTFE COATED FULL DIAMETER SECTIONS) PROXIMAL TO THE DISTAL TIP REGION. UNFORTUNATELY, THE FRACTURE SECTION IS NOT CLEARLY FOCUSED IN THE PHOTOS CAPTURED. WITH ONLY A HAND-MAGNIFIER AND HAND HELD CAMERA AVAILABLE, ONLY A CURSORY REVIEW OF THE NON-STERILE FRACTURED GUIDEWIRE PROXIMAL SECTION WAS POSSIBLE. THE DISTAL END REGION OF THE GUIDEWIRE CONSISTS OF A REDUCED DIAMETER FLEXIBLE COREWIRE WITH A RADIOPAQUE COILWIRE COILED AROUND THE STRAIGHT COREWIRE. A PORTION OF THE DISTAL END OF THE COREWIRE IS FLATTENED TO FACILITATE STEERABILITY. THE FRACTURE OF THE GUIDEWIRE APPEARED TO BE IN, OR AT THE DISTAL END OF, THE FLATTENED 'RIBBON' SECTION OF THE GUIDEWIRE, CONSISTENT WITH THE FLATTENED SECTION OF THE GUIDEWIRE TIP BEING THE SMALLEST CROSS-SECTION PORTION OF THE GUIDEWIRE. THE FRACTURE OCCURRED APPROXIMATELY ONE INCH (~2.5 CM) DISTAL TO THE DISTAL END OF THE PTFE SLEEVE. SINCE THE ENTIRE LENGTH OF THE DISTAL TIP AREA OF THE MANUFACTURED GUIDEWIRE IS APPROX 1.1 INCH PAST THE END OF THE PTFE SLEEVE, IT IS BELIEVED THAT MOST OF THE INNER STAINLESS STEEL COREWIRE OF THE GUIDEWIRE WAS RETRIEVED. THE FLATTENED RIBBON SECTION CONTAINED 3 HALF-TWISTS, INDICATING THAT THERE WAS SOME MINOR ROTATION OF THE GUIDEWIRE AFTER THE TIP BECAME TRAPPED, BUT THAT THE FAILURE WAS NOT PRIMARILY TORSIONAL (A TORSIONAL FRACTURE WOULD HAVE MANY TWISTS). THERE WAS NO INDICATION OF FOLDING VISIBLE AT THE FRACTURE SURFACE VISIBLE WITH UNAIDED EYE, INDICATING THAT THE FRACTURE WAS TOTALLY OR PRIMARILY DUE TO TENSILE OVERLOAD. THE SURROUNDING RADIOPAQUE COILWIRE WAS STRETCHED TOTALLY STRAIGHT AS WOULD BE EXPECTED WITH TENSILE OVERLOAD FOLLOWING COREWIRE FRACTURE, AND APPROXIMATELY ONE INCH OF THE STRETCHED COILWIRE WAS RETRIEVED. THE RELATIVELY SMALL AMOUNT OF COIL WIRE RETRIEVED INDICATES THAT THE COILWIRE FRACTURED NEAR THE PROXIMAL AREA OF THE COILWIRE, LEAVING SEVERAL INCHES BEHIND. THE SURROUNDING COILWIRE IS CONSTANT DIAMETER, AND COULD FAIL AT ANY POINT ALONG THE LENGTH. THE COILWIRE HAS LESS TENSILE STRENGTH THAT THE INNER COREWIRE. IF THE TIP OF THE INTACT GUIDEWIRE WERE TRAPPED AND THE FORCE TO RETRIEVE THE GUIDEWIRE WAS SUFFICIENTLY LARGE TO BREAK THE INNER COREWIRE, THE SURROUNDING COILWIRE WOULD BE EXPECTED TO STRETCH, AND THEN BREAK. THE FLUOROSCOPY IMAGES INDICATED THAT THE DISTAL TIP OF THE GUIDEWIRE WAS PLACED FAR DISTAL TO THE LESION DURING THE ANGIOPLASTY AND STENT EXPANSION. THE FINAL FLUOROSCOPY IMAGES INDICATE THAT THE GUIDEWIRE BECAME TRAPPED IN THE PROMUS STENT DURING REMOVAL. THE DISTAL TIP OF THE GUIDEWIRE IS CLEARLY VISIBLE IN THE APPARENTLY DEFORMED STENT. THERE WAS NO INDICATION WHATEVER THAT THERE WAS ANY MALFUNCTION OF THE GUIDEWIRE. I CONCLUDE THAT THE GUIDEWIRE BECAME TRAPPED IN THE STENT DURING WITHDRAWAL, AND FRACTURED CONSISTENT WITH BEING PULLED BEYOND THE INHERENT STRENGTH OF THE GUIDEWIRE. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL LIMITED AND WAS DETERMINED TO BE ACCEPTABLE. FILM AND CASE REVIEW: THE CASE INCLUDED A NARRATIVE DESCRIPTION AND A SINGLE CD-ROM OF A PROCEDURE PERFORMED ON A (B)(6) OLD MALE. THE PATIENT'S ANGIOGRAM REVEALED A PATIENT WITH SEVERE LEFT VENTRICULAR DYSFUNCTION. THE PATIENT'S ESTIMATED EJECTION FRACTION WAS 25% AND HAD PREVIOUSLY UNDERGONE DEFIBRILLATOR PLACEMENT AND EXTENSIVE INTERVENTION TO THE PROXIMAL AND MID-SEGMENT OF THE LEFT ANTERIOR DESCENDING. THERE WAS A FOCAL STENOSIS IN THE PROXIMAL CIRCUMFLEX OF APPROXIMATELY 85% LUMINAL NARROWING. THE VESSEL WAS LARGE IN CALIBER. THE PATIENT UNDERWENT INTERVENTION WITH AN ATW WIRE AND PRE-DILATION OF THE LESION AND THEN DEPLOYMENT OF A 3.5 X 18 PROMO STENT. THE PATIENT HAD POST-DILATION OF THE STENT WITH A 3.5 HIGH PRESSURE BALLOON AND FOLLOWING THIS APPARENTLY THERE WAS AN ATTEMPT TO REMOVE THE WIRE AND THE DISTAL SEGMENT WAS AVULSED AND LEFT IN THE PATIENT. APPARENTLY THERE WAS NO FINDINGS PRIOR TO THE WIRE BEING INTRODUCED OF ANY PROBLEMS WITH IT AND IT WAS REMOVED APPROPRIATELY FROM THE PACKAGE. THERE WAS A CONCERN OVER STENT FRACTURE AND AT THE END OF THE PROCEDURE THE PATIENT WAS TAKEN TO THE RECOVERY UNIT IN STABLE CONDITION, RETURNED FOR REPEAT CATHETERIZATION SEVERAL DAYS LATER WHERE THE FLOW DOWN THE VESSEL AS APPROPRIATE HOWEVER THE PATIENT WAS SUBJECTED TO MITRAL VALVE REPAIR AND CORONARY BYPASS GRAFTING AND REMOVAL OF THE DISTAL WIRE TIP. THE PATIENT SUCCUMBED TO COMPLICATIONS OF THE PROCEDURE SEVERAL DAYS LATER. UPON REVIEW OF THE FILMS, THE VESSEL WAS NOT TORTUOUS, WAS NOT HEAVILY CALCIFIED NOR WAS IT A SMALL CALIBER VESSEL. THE RESULTS ARE COMPLETELY UNEXPECTED AND UNANTICIPATED IN THIS SCENARIO HOWEVER THERE ARE SEVERAL FEATURES THAT MAY HAVE LEAD TO THE COMPLICATION. THE ANGIOGRAMS UPON MY REVIEW ARE INADEQUATE IN THAT THE DISTAL WIRE TIP IS NOT WELL VISUALIZED THROUGHOUT THE STUDY. AT THE END THE PROCEDURE IT IS NOTED THAT THE GUIDE IS DEEPLY ENGAGED INTO THE LEFT MAIN AND CIRCUMFLEX CREATING THE POSSIBILITY THAT THERE MAY HAVE BEEN SOME TRAUMA ON THE WIRE SEGMENT. THE POSSIBILITY OF THE WIRE BEING TRAPPED IN THIS STENT WHICH APPARENTLY FRACTURED IS ANOTHER POTENTIAL REASON WHY THIS COMPLICATION MAY HAVE OCCURRED. IN GENERAL, VERY CAREFUL VISUALIZATION OF THE DISTAL WIRE TO AVOID ENTRAPMENT IN SMALL MICRO-BRANCHES AND CARE IN PREVENTING UNNECESSARY DEEP ENGAGEMENT AND ANGULATION OF THE GUIDE UPON REMOVAL OF THE GUIDE WIRE SHOULD BE TAKEN. FURTHERMORE, THIS VESSEL APPEARED TO BE 4-0 IN CALIBER UNDERSIZING OF THE STENT WITH HIGH PRESSURE POST INFLATION MAY HAVE LEAD TO THE POSSIBILITY OF STENT FRACTURE THOUGH I DO NOT KNOW WHAT PRESSURES WERE UTILIZED TO POST DILATE THIS LESION SO FURTHER COMMENT IS NOT POSSIBLE. CONCLUSION: THE COMPLAINT OF FRACTURED / SEPARATED IN THE PATIENT WAS CONFIRMED. VISUAL INSPECTION AND PROCEDURAL FILM REVIEW SUGGESTS THAT THE WIRE UNDERWENT MANIPULATION AND STRESS THAT CONTRIBUTED TO THE FRACTURE AND SEPARATION. THERE IS NO EVIDENCE IN EITHER THE PRODUCT REVIEW OF DHR REVIEW TO SUGGEST MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE CORDIS STEERABLE GUIDEWIRE IFU STATES: GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR COIL SEPARATION, BENDS, OR KINKS. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. DAMAGE WILL PREVENT THE GUIDEWIRE FROM PERFORMING WITH ACCURATE TORQUE RESPONSE AND CONTROL. GUIDEWIRE MANIPULATION/TORQUING SHOULD ALWAYS BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY. TORQUING THE GUIDEWIRE AGAINST RESISTANCE MAY CAUSE DAMAGE AND/OR FRACTURE WHICH MAY RESULT IN SEPARATION OF THE DISTAL TIP. SHOULD THE GUIDEWIRE TIP BECOME ENTRAPPED WITHIN THE VASCULATURE (I.E., SMALL SIDE BRANCH, TIGHT STENOSIS), DO NOT TORQUE THE GUIDEWIRE. ADVANCE THE BALLOON CATHETER DISTALLY, GENTLY PULL THE GUIDEWIRE BACK INTO THE BALLOON CATHETER, AND REMOVE THE BALLOON CATHETER/GUIDEWIRE SYSTEM AS A UNIT. SHOULD TORQUE CONTROL/TIP RESPONSE BE COMPROMISED DURING USE, CONFIRM TIP INTEGRITY USING FLUOROSCOPY. LOSS OF TORQUE CONTROL MAY BE DUE TO CORE WIRE FRACTURE. UNDER FLUOROSCOPIC GUIDANCE, ADVANCE THE BALLOON CATHETER TO THE DISTAL END OF THE GUIDEWIRE AND REMOVE THE BALLOON CATHETER/GUIDEWIRE SYSTEM AS A UNIT. WHILE STROKE IS NOT SPECIFICALLY MENTIONED IN THE IFU, THE POSSIBILITY OF DEVICE FRACTURE AND SEPARATION IS STATED IN THE IFU. THE RETAINED PORTION WAS RETRIEVED IN A PROCEDURE PERFORMED FOR MULTIPLE INDICATIONS, INCLUDING THE DEVICE RETRIEVAL AS WELL AS TREATMENT OF THE EXISTING CORONARY DISEASE AND MITRAL VALVE DYSFUNCTION. THIS PATIENT WAS AT VERY HIGH-RISK FOR PERI-SURGICAL COMPLICATIONS SIMPLY DUE TO HIS COMPLICATED MEDICAL STATUS AND ADVANCED DISEASE. STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY BYPASS GRAFTING AND VALVE REPAIR SURGERIES AS WELL AS ANY OPEN RETRIEVAL OF A RETAINED DEVICE. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL, VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED FAILURE AND REPORTED EVENTS.
POST DILATION WAS SUBSEQUENTLY PERFORMED IN THE MID SEGMENT OF THE STENT WITH A 3.5MM HIGH PRESSURE BALLOON BECAUSE OF A MILD INDENTATION IN THAT AREA. THE NEXT INJECTION SHOWED WHAT APPEARED TO BE AN EXCELLENT RESULT WITH TIMI GRADE III FLOW. AT THAT POINT, THE GUIDEWIRE WAS REMOVED WITH SOME DIFFICULTY BECAUSE OF RESISTANCE IN THE MID SEGMENT OF THE STENTED AREA. THE PROCEDURE REPORT STATED THAT THE WIRE WAS FINALLY REMOVED WITH RETENTION OF THE VERY DISTAL TIP NOTED. SUBSEQUENT INJECTION STRONGLY SUGGESTED THAT THERE WAS STENT MALFUNCTION WITH FRACTURE AND MILD DISTAL MIGRATION AND "CRUMPLING" OF THE PROXIMAL SEGMENT. MULTIPLE ATTEMPTS TO REGAIN ACCESS INTO THE DISTAL VESSEL WERE UNSUCCESSFUL. THE FOLLOWING DAY, A REPEAT CATHETERIZATION REVEALED THAT THE CIRCUMFLEX ARTERY HAD EXCELLENT FLOW AND THERE DID NOT APPEAR TO BE ANY ILL-EFFECTS FROM THE STENT MALFUNCTION. THE MAJOR PROBLEM CONTINUED TO BE THE SEVERE MITRAL REGURGITATION IN THE SETTING OF SIGNIFICANT LEFT VENTRICULAR DYSFUNCTION. APPROXIMATELY SIX DAYS LATER, THE PATIENT UNDERWENT MITRAL VALVE REPAIR, CORONARY ARTERY BYPASS GRAFTING (CABG) OF THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL, AND RETRIEVAL OF THE WIRE TIP IN THE ASCENDING AORTA AND LEFT MAIN CORONARY. THE DISCUSSION TO PERFORM THE SURGERY WAS BASED ON THE SEVERE MITRAL REGURGITATION IN ADDITION TO THE RETAINED WIRE AND WORRY THAT THE CIRCUMFLEX VESSEL MAY OCCLUDE BECAUSE OF THE STENT MALFUNCTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE HEART WAS EXTREMELY DILATED AND THE RIGHT HEART WAS POORLY FUNCTIONING. THE EJECTION FRACTION WAS APPROXIMATELY 10 TO 15%. THE HEART BEGAN TO FAIL VERY QUICKLY; HOWEVER, THE CARDIOPULMONARY BYPASS WAS PERFORMED QUICKLY AND THE PATIENT MAINTAINED A GOOD BLOOD PRESSURE THROUGHOUT THIS TIME WITH A MEAN ARTERIAL PRESSURE OF APPROXIMATELY 65. A SMALL TRANSVERSE AORTOTOMY WAS PERFORMED AND A SMALL WIRE WAS SEEN TO BE EMANATING FROM THE LEFT MAIN CORONARY ARTERY. THE WIRE WAS GRABBED WITH FORCEPS AND EASILY REMOVED. THE END OF THE WIRE FROM THE DESCENDING AORTA PULLED OUT EASILY THROUGH THE CROSSCLAMP AND WAS RETRIEVED. THE WIRE WAS NOTED TO BE 15 ½ CM IN LENGTH. THE AORTOTOMY WAS RECLOSED. THE BYPASS GRAFT AND VALVE REPLACEMENT WERE THEN COMPLETED AND THE PATIENT WAS WEANED FROM BYPASS. THE LEFT VENTRICULAR EJECTION FRACTION APPEARED TO BE APPROXIMATELY 15% AND THE RIGHT VENTRICLE APPEARED TO BE POOR AS WELL. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT IN STABLE CONDITION, HOWEVER DID NOT REGAIN CONSCIOUSNESS. A CT OF THE BRAIN LATER THAT DAY SHOWED A LARGE ISCHEMIC INFARCT WHICH INVOLVED THE RIGHT CEREBRAL HEMISPHERE FRONTAL LOBE, ANTERIOR TEMPORAL LOBE, AND PARIETAL LOBES, AS WELL AS THE LEFT CEREBRAL HEMISPHERE FRONTAL LOBE AND MESIAL TEMPORAL REGION. CT OF THE BRAIN THE FOLLOWING DAY SHOWED INTERVAL WORSENING OF THE CEREBRAL EDEMA IN THE BILATERAL HEMISPHERES WITH COMPLETE EFFACEMENT OF LATERAL VENTRICLES, SUPRASELLAR CISTERN, PREPONTINE CISTERNS, AND FOURTH VENTRICLE UNCAL HERNIATION. EXTENSION OF THE EDEMA INVOLVED THE BRAINSTEM AND CEREBELLAR HEMISPHERES. A NUCLEAR MEDICINE BRAIN SCAN THE NEXT DAY SHOWED BRAIN DEATH. A NEUROLOGICAL CONSULT STATED THAT THE PATIENT SUFFERED BIHEMISPHERIC INFARCTS POSSIBLY DUE TO CARDIOEMBOLIC SOURCE. THE PATIENT EXPIRED APPROXIMATELY FIVE DAYS AFTER THE CABG SURGERY. (CONCOMITANT MEDICAL PRODUCTS): 3.5 X 18MM PROMUS STENT, MAVERICK MONORAIL 3.5 X 8 BALLOON. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(6) AND WAS DETERMINED TO BE ACCEPTABLE. THE DEVICE COULD NOT BE OBTAINED FROM THE FACILITY, THEREFORE, CORDIS EMPLOYEES WENT TO THE FACILITY TO EVALUATE THE DEVICE. THEIR EVALUATION IS NOT YET COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.
A SGW ATW .014 STR FLOPPY 195 CM GUIDEWIRE TIP BROKE OFF AND WAS IN THE LEFT MAIN CORONARY TO AORTA. THE WIRE HAD BEEN REMOVED FROM THE DISPENSER BY THE DISTAL FLOPPY END AND DID NOT APPEAR DAMAGED PRIOR TO USE. THE WIRE WAS RE-SHAPED WITH SLIGHT CURVING WITH AN INTRODUCER BY THE PHYSICIAN. THE TARGET VESSEL WAS THE LEFT CIRCUMFLEX ARTERY, WHICH WAS DIFFUSELY ATHEROSCLEROTIC WITH A HIGH GRADE STENOSIS IN THE PROXIMAL VESSEL AND 50% STENOSIS IN THE PROXIMAL PORTION OF A LARGE SECOND OBTUSE MARGINAL BRANCH. THE INDICATION FOR THE PROCEDURE WAS NON-ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR CONGESTIVE HEART FAILURE, SEVERE ISCHEMIC CARDIOMYOPATHY WITH ESTIMATED LEFT VENTRICULAR EJECTION FRACTION OF 15% AND SEVERE MITRAL REGURGITATION. THERE HAD BEEN NO DIFFICULTY IN TRACKING THE WIRE THROUGH THE VESSEL OR LESION, AND THE WIRE BEHAVED NORMALLY DURING TORQUE. THE TIP DID NOT PROLAPSE DURING TREATMENT, AND WAS ADVANCED INTO THE DISTAL VASCULATURE. THE LESION WAS PRE-DILATED WITH A 3.5MM MAVERICK BALLOON AND A 3.5 X 18MM PROMUS STENT WAS SUCCESSFULLY DEPLOYED IN THE PROXIMAL VESSEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATW GUIDEWIRE | CARDIOLOGY WIRES & METALS (DQX) | DQX | CORDIS CORPORATION | NA | F0210879 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death| R| S |