PALMAZ STENT UNKNOWN
Report
- Report Number
- 9616099-2013-00220
- Event Type
- Death
- Date Received
- April 16, 2013
- Date of Event
- July 25, 2003
- Report Date
- March 19, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS REPORT REPRESENTS TWO (2 EACH) PRODUCTS WITH AN UNKNOWN CATALOG AND LOT NUMBER.
AS REPORTED IN A LITERATURE ARTICLE, A CASE OF STENTING FOR NATIVE COARCTATION IS DESCRIBED IN A PATIENT WITH A FATAL DISSECTION AFTER IMPLANTATION. THE HISTOLOGY OF THE AORTA IN COARCTATION AND IN THE ELDERLY IS DESCRIBED. THE EXPERIENCE OF STENTING IN OLDER PATIENTS IS REVIEWED AND DISCUSSED. THE PATIENT HAD TWO (2 EACH) 50 MM. PALMAZ GENESIS STENTS IMPLANTED DURING THE PROCEDURE. THE PATIENT HAS A HISTORY OF HYPERTENSION AND HAS NO FAMILY HISTORY OF MARFAN'S SYNDROME OR OTHER CONNECTIVE TISSUE DISORDERS. THE PATIENT WAS TAKING MEDICATION TO CONTROL BLOOD PRESSURE. CATHETERIZATION WAS ACHIEVED THROUGH THE RIGHT FEMORAL ARTERY. THE CATHETER AND GUIDE WIRE (COMPETITOR PRODUCTS) WERE USED TO CROSS THE LESION. AN ANGIOGRAM IN LEFT LATERAL PROJECTION REVEALED A TORTUOUS AREA OF COARCTATION WITH SOME CALCIFICATION. THE STENT WAS POSITIONED ACROSS THE COARCTATION. A LOW PROFILE BALLOON 20 MM (COMPETITOR PRODUCT) WAS USED TO INFLATE THE STENT TO MAXIMUM SIZE. THE STENT APPEARED TO BE EXPANDED AGAINST THE ISTHMUS AND SITE OF THE COARCTATION, BUT WAS CLEARLY UNDERSIZED IN THE POTSTENOTIC AREA. A 25 MM BALLOON WAS ADVANCED INTO THE STENT. TWO INFLATIONS WERE CARRIED OUT AND DURING THE SECOND INFLATION THE STENT MIGRATED DISTAL TO THE COARCTATION. ANGIOGRAPHY SHOWED THAT THE STENT WAS WELL WITHIN THE LUMEN OF THE AORTA, WITH A SIGNIFICANT GAP BETWEEN THE OUTER MARGIN OF THE STENT AND THE AORTIC WALL. THE STENT WAS STABILIZED JUST BEYOND THE COARCTATION AND A SECOND WIRE WAS ADVANCED THROUGH THE SENT. TWO 15 MM BALLOONS WERE POSITIONED WITHIN THE STENT AND SIMULTANEOUSLY INFLATED. FOLLOWING THIS THE STENT WAS STILL UNDERDEPLOYED AND MOBILE WITHIN THE DESCENDING AORTA. ONE 20 MM DIAMETER BALLOON WAS INFLATED WITH FULL DEPLOYMENT AGAINST THE AORTIC WALL, AND WITH A STABLE STENT POSITION AGAINST AORTIC WALL. AN ANGIOGRAM WAS OBTAINED TO CONFIRM STENT POSITION JUST BELOW THE COARCTATION A SECOND 50 MM LENGTH STENT WAS THEN MOUNTED ON A 20 MM BALLOON AND ADVANCED THROUGH A LONG SHEATH TO COVER THE SITE OF THE COARCTATION AND ABUT AGAINST THE PROXIMAL MARGINS OF THE FIRST 50 MM STENT. THE SECOND STENT WAS DEPLOYED AND REMAINED IN POSITION, BUT APPEARED UNDERDEPLOYED WHEN COMPARING TO THE MARGINS OF THE AORTA. A 15 MM BALLOON WAS PASSED ALONGSIDE THE 20 MM BALLOON AND SIMULTANEOUS PARTIAL INFLATIONS OF BOTH BALLOONS ALLOWED FULL DEPLOYMENT OF THE STENT. A FINAL ANGIOGRAM SHOWED BOTH STENTS IN GOOD POSITION WITH APPOSITION TO THE WALL OF THE AORTA AND AN APPROPRIATE SIZE FOR THE REFERENCE AORTIC DIAMETER OF 21 MM. THERE WAS NO GRADIENT ON PULLBACK THROUGH THE STENTS. THE PATIENT WAS RETURNED TO THE RECOVERY AREA AND SHORTLY THEREAFTER DEVELOPED SUDDEN SEVERE CIRCULATORY COLLAPSE, FOR WHICH INTRAVENOUS FLUIDS WERE RAPIDLY INFUSED AND BLOOD PRESSURE RESTORED. THERE WERE NO ELECTROCARDIOGRAPHIC CHANGES. ULTRASONOGRAPHY REVEALED A LARGE ECHODENSE AREA AT THE BASE, IN THE LEFT CHEST, CONSISTENT WITH HEMOTHORAX. CARDIOVASCULAR SURGERY AND VASCULAR SURGERY WERE CONSULTED. THE PATIENT WAS RETURNED TO THE CATHETER LABORATORY FOR EMERGENCY ANGIOGRAPHY. A RUPTURE IN THE AORTIC WALL AT THE SITE OF THE COARCTATION WAS APPARENT, WITH EXTRAVASATION OF DYE INTO A LARGE SACCULAR SPACE ON THE POSTERIOR ASPECT OF THE AORTA. ARRANGEMENTS WERE MADE FOR PLACEMENT OF A COVERED STENT IN AN ATTEMPT TO OCCLUDE THE RUPTURE, WHILE OPERATING THEATER FOR URGENT SURGERY WAS PREPARED. HOWEVER, THE PATIENT DETERIORATED WITHIN MINUTES TO AN AGONAL RHYTHM FROM WHICH SHE COULD NOT BE RESUSCITATED. AUTOPSY: EXTENSIVE SUPERIOR MEDIASTINAL AND BILATERAL PLEURAL HEMORRHAGE WITH HEMATOMA AROUND ASCENDING AORTA, EXTENDING ONTO THE AORTIC ARCH PROXIMALLY AND FOR 10 CM OVER THE THORACIC AORTA. WITHIN THE AORTA, TWO STENTS WERE IN PLACE, AND THERE WAS EVIDENCE OF COARCTATION WITH RUPTURE OF THE POSTERIOR WALL OF THE AORTA, ADJACENT TO THE DISTAL HALF OF THE PROXIMAL STENT. THE RUPTURE SITE MEASURED 10 MM. LINEAR FOLDS WERE SEEN WITHIN THE AORTIC INTIMA, SUGGESTIVE OF AN AORTOPATHY. THE INTIMAL SURFACE SHOWS THE HATCH MARKS CORRESPONDING TO THE STENT STRUTS. AREAS OF SUPERFICIAL AND DEEP MEDIAL TEARS ARE SEEN IN ADDITION TO THE FULL THICKNESS TEAR . AREAS OF DIMINISHED NUMBERS OF MEDIAL SMOOTH MUSCLE CELLS, COLLAPSE AND DISORGANIZATION OF MEDIAL ELASTIC PLATES WERE EVIDENT. THE CHANGES WERE CONFINED TO THE AORTA. NONE OF THE OTHER VASCULAR SECTIONS SHOWED ANY OF THESE LESIONS. AREAS CORRESPONDING TO THE STRUTS THE STENT SHOWED INTIMAL AND MEDIAL COMPRESSION WITH INDENTATION OF THE WALL AND A SURFACE RIM OF RECENT THROMBUS. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. ADDITIONALLY AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, REVIEW OF THE MANUFACTURING RECORDS (DHR) COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. AORTIC DISSECTION OR RUPTURE IS A RARE BUT POTENTIALLY DEVASTATING COMPLICATION OF STENT IMPLANTATION FOR AORTIC COARCTATION. AN IMPORTANT RISK FACTOR FOR THIS COMPLICATION IS ADVANCED AGE. BALLOON DILATION AND ENDOVASCULAR STENT IMPLANTATION RELIEVES THE AORTIC OBSTRUCTION (COARCTATION) BY TEARING THE COARCTATION SHELF WITH VARIABLE EXTENSION INTO THE MEDIA. TEARS INTO THE ADJACENT "NORMAL" AORTIC WALL MAY REFLECT AN INHERENT WEAKNESS IN THE AORTA IN PATIENTS WITH COARCTATION. IF EXTENSIVE, THESE TEARS CAN LEAD TO ACUTE RUPTURE OR DISSECTION AND CHRONIC ANEURYSM FORMATION. THE RATIONALE FOR STENT IMPLANTATION IS THAT OVERDILATION OF THE COARCTATION SEGMENT IS UNNECESSARY, THUS AVOIDING MAJOR TRANSMURAL TEARS WHILE AT THE SAME TIME THE STENT STRUTS WILL SPLINT ANY SMALLER TEARS AGAINST THE AORTIC WALL, PREVENTING PROGRESSIVE DISSECTION AND ANEURYSM FORMATION. ADDITIONALLY, THE ACUTE ELASTIC RECOIL OF THE COARCTATION SEGMENT, WHICH CONTRIBUTES TO A SUBOPTIMAL INITIAL RESULT AND LATE RECOARCTATION, IS PREVENTED BY STENT IMPLANTATION, LEADING TO A GREATER RELIEF OF OBSTRUCTION THAN WITH BALLOON DILATION ALONE. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THIS DOES NOT REPRESENT DEVICE MALFUNCTION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL / LESION CHARACTERISTICS AND POSSIBLY PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. PLEASE NOTE THAT THIS REPORT REPRESENTS TWO (2 EACH) PRODUCTS WITH AN UNKNOWN CATALOG AND LOT NUMBER.
THIS IS A REPORT OF BLOOD LEAKS AROUND THE ARTERIAL AND VENOUS END CAPS OF THE DIALYZER AFTER 9 REUSES. THERE WAS APPROXIMATELY 200ML BLOOD LOSS. TREATMENT WAS ENDED AND RESTARTED WITH A NEW DIALYZER WITH NO OTHER ISSUES.
MCLAUGHLIN ET AL AORTIC DISSECTION AFTER STENT DILATATION FOR COARCTATION OF THE AORTA: A CASE REPORT AND LITERATURE REVIEW; CATHETER CARDIOVASC INTERV. 2003 AUG;59(4):528-35; A CASE OF STENTING FOR NATIVE COARCTATION IS DESCRIBED IN A PATIENT WITH A FATAL DISSECTION AFTER IMPLANTATION. THE HISTOLOGY OF THE AORTA IN COARCTATION AND IN THE ELDERLY IS DESCRIBED. THE EXPERIENCE OF STENTING IN OLDER PATIENTS IS REVIEWED AND DISCUSSED. THE PATIENT HAD TWO (2 EACH) 50 MM. PALMAZ GENESIS STENTS IMPLANTED DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163539 | PALMAZ STENT UNKNOWN | ENDOVASCULAR SDS/STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |