PALMAZ GENESIS 8 X 18, 80CM
Report
- Report Number
- 9610978-2011-00008
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- December 16, 2010
- Report Date
- February 15, 2011
- Manufacturer
- CORDIS EUROPA, N.V.
- Product Code
- FGE
- PMA / PMN Number
- K012056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
THE(B)(6) PATIENT HAD THE FOLLOWING MEDICAL HISTORY: PREVIOUSLY UNDERGONE LEFT FEMOROPOPLITEAL BYPASS GRAFT FOR AN OSTIAL SFA OCCLUSION, WHICH GRAFT SUBSEQUENTLY BECAME OCCLUDED. THE GRAFT WAS PLACED IN (B)(6) 2009. THEN IN (B)(6) 2009 ALSO UNDERWENT SELF-EXPANDING STENTING OF THE RIGHT COMMON ILIAC AND RIGHT EXTERNAL ILIAC ARTERY, WITH PLACEMENT OF 7 X 16 AND 6 X 100 EDWARDS LIFESTENTS. HE SUBSEQUENTLY OCCLUDED THE RIGHT COMMON ILIAC ARTERY STENT. HE NOW HAS SEVERE BILATERAL CLAUDICATION. PATIENT HAD RIGHT COMMON ILIAC ARTERY OCCLUSION AS WELL AS OCCLUSION IN THE LEFT SFA, WITH RECONSTITUTION AT THE MID POPLITEAL ARTERY,WITH THREE-VESSEL RUNOFF ON THE LEFT LOWER EXTREMITY. PATIENT HAD SUCCESSFUL PERMANENT RECANALIZATION OF THE RIGHT COMMON ILIAC ARTERY OCCLUSION AND STENT GRAFT PLACEMENT WITH AN 8 X 58 ICAST STENT. PATIENT ALSO HAD SUCCESSFUL LEFT COMMON ILIAC ARTERY STENTING WITH PLACEMENT OF AN 8 X 18 MM PALMAZ GENESIS STENT. POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND PLAVIX. THREE MONTHS AFTER THE PROCEDURE, THE PATIENT RETURNED FOR RECANALIZATION OF HIS KNOWN LEFT SFA OCCLUSION. PREVIOUSLY IMPLANTED STENTS WERE NOTED TO BE WIDELY PATENT. USING A UF CATHETER AND GLIDEWIRE, LEFT ILIAC ARTERY WAS ACCESSED AND THE UF CATHETER WAS THEN ADVANCED DOWN TO THE LEVEL OF THE MID LEFT PROFUNDA FEMORAL ARTERY (THERE IS A LEFT OSTIAL SFA OCCLUSION). THE GLIDEWIRE WAS THEN EXCHANGED FOR A GLIDE ADVANTAGE WIRE. IN STANDARD FASHION, USING A 6-FRENCH DESTINATION SHEATH, THIS WAS BROUGHT DOWN TO THE LEVEL OF THE DISTAL LEFT COMMON ILIAC ARTERY IN STANDARD UP AND OVER FASHION. THERE WAS SOME RESISTANCE IN ADVANCING THE SHEATH THROUGH THE LEFT COMMON ILIAC ARTERY GENESIS STENT, BUT WAS ABLE TO ADVANCE TO THE DISTAL COMMON ILIAC ARTERY. AT THIS POINT, IT WAS NOTED THAT THERE HAD BEEN A COMPLETE DISLODGEMENT OF THE DISTAL HALF OF THE LEFT COMMON ILIAC ARTERY GENESIS STENT. THE ANGULATION WAS IN A NONCOAXIAL ALIGNMENT. IT ALSO WAS NOTED THAT THE GLIDEWIRE HAD LIKELY TRAVERSED A DISTAL STENT STRUT. ACCESS WAS THEN OBTAINED FROM THE LEFT COMMON FEMORAL ARTERY AND A 6-FRENCH TERUMO SHEATH WAS PLACED USING ULTRASOUND GUIDANCE. NEXT, A KUMPE CATHETER AND GLIDEWIRE WERE USED TO WIRE THROUGH THE DISLODGED STENT SEGMENT. GLIDEWIRE WERE USED TO WIRE THROUGH THE DISLODGED STENT SEGMENT. INITIALLY, BALLOON ANGIOPLASTY WAS GOING TO BE PERFORMED TO SECURE THE STENT FRAGMENT IN PLACE. HOWEVER, GIVEN THE NON-COAXIAL ALIGNMENT OF THE STENT, THERE WAS CONCERN FOR VESSEL PERFORATION WITH BOTH BALLOON AND EVEN POSSIBLY WITH THE COVERED STENT. NO FURTHER MANIPULATION OF THE STENT WAS PERFORMED. IT WAS DECIDED THAT GIVEN NORMAL FLOW THROUGH THE DISLODGED STENT FRAGMENT AND ITS LOCATION ABOVE THE HYPOGASTRIC ARTERY AND THE COMMON ILIAC ARTERY THAT THE BEST PLAN WOULD BE TO OBSERVE THE PATIENT IN ICAR OVERNIGHT FOR VASCULAR RECOVERY. PULSES AND DOPPLERS WILL BE CHECKED IN SERIAL FASHION AND IF HE MAINTAINS GOOD PERFUSION, THE STENT FRAGMENT WILL REMAIN IN PLACE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
THE (B)(6) MALE PATIENT HAD THE FOLLOWING MEDICAL HISTORY: PREVIOUSLY UNDERGONE LEFT FEMOROPOPLITEAL BYPASS GRAFT FOR AN OSTIAL SFA OCCLUSION, WHICH GRAFT SUBSEQUENTLY BECOME OCCLUDED. THE GRAFT WAS PLACED IN (B)(6) 2009. THEN IN (B)(6) 2009, ALSO UNDERWENT SELF-EXPANDING STENTING OF THE RIGHT COMMON ILIAC AND RIGHT EXTERNAL LILAC ARTERY, WITH PLACEMENT OF 7 X 16 AND 6 X 100 EDWARDS LIFESTENTS. HE SUBSEQUENTLY OCCLUDED THE RIGHT COMMON ILIAC ARTERY STENT. HE NOW HAS SEVERE BILATERAL CLAUDICATION. PATIENT HAD RIGHT COMMON ILIAC ARTERY OCCLUSION AS WELL AS OCCLUSION IN THE LEFT SFA, WITH RECONSTITUTION AT THE MID POPLITEAL ARTERY, WITH THREE-VESSEL RUNOFF ON THE LEFT LOWER EXTREMITY. PATIENT HAD SUCCESSFUL PERMANENT RECANNULIZATION OF THE RIGHT COMMON ILIAC ARTERY OCCLUSION AND STENT GRAFT PLACEMENT WITH AN 8 X 58 ICAST STENT. PATIENT ALSO HAD SUCCESSFUL LEFT COMMON ILIAC ARTERY STENTING WITH PLACEMENT OF AN 8 X 18 MM PALMAZ GENESIS STENT. POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND PLAVIX. THREE MONTHS AFTER THE PROCEDURE, THE PATIENT RETURNED FOR RECANNULIZATION OF HIS KNOWN LEFT SFA OCCLUSION. PREVIOUSLY IMPLANTED STENTS WERE NOTED TO BE WIDELY PATENT. USING A UF CATHETER AND GLIDEWIRE, LEFT ILIAC ARTERY WAS ACCESSED AND THE UF CATHETER WAS THEN ADVANCED DOWN TO THE LEVEL OF THE MID LEFT PROFUNDA FEMORAL ARTERY (THERE IS A LEFT OSTIAL SFA OCCLUSION). THE GLIDEWIRE WAS THEN EXCHANGED FOR A GLIDE ADVANTAGE WIRE. IN STANDARD FASHION, USING A 6-FRENCH DESTINATION SHEATH, THIS WAS BROUGHT THIS WAS BROUGHT DOWN TO THE LEVEL OF THE DISTAL LEFT COMMON ILIAC ARTERY IN STANDARD UP AND OVER FASHION. THERE WAS SOME RESISTANCE IN ADVANCING THE SHEATH THROUGH THE LEFT COMMON ILIAC ARTERY GENESIS STENT, BUT WAS ABLE TO ADVANCE TO THE DISTAL COMMON ILIAC ARTERY. AT THIS POINT, IT WAS NOTED THAT THERE HAD BEEN A COMPLETE DISLODGEMENT OF THE DISTAL HALF OF THE LEFT COMMON ILLIAC ARTERY GENESIS STENT. THE ANGULATION WAS IN A NONCOAXIAL ALIGNMENT. IT ALSO WAS NOTED THAT THE GLIDEWIRE HAD LIKELY TRAVERSED A DISTAL STENT STRUT. ACCESS WAS THEN OBTAINED FROM THE LEFT COMMON FEMORAL ARTERY AND A 6-FRENCH TERUMO SHEATH WAS PLACED USING ULTRASOUND GUIDANCE. NEXT, A KUMPE CATHETER AND GLIDEWIRE WERE USED TO WIRE THROUGH THE DISLODGED STENT SEGMENT. INITIALLY, BALLOON ANGIOPLASTY WAS GOING TO BE PERFORMED TO SECURE THE STENT FRAGMENT IN PLACE. HOWEVER, GIVEN THE NON-COAXIAL ALIGNMENT OF THE STENT, THERE WAS CONCERN FOR VESSEL PERFORATION WITH BOTH BALLOON AND EVEN POSSIBLY WITH THE COVERED STENT. NO FURTHER MANIPULATION OF THE STENT WAS PERFORMED. IT WAS DECIDED THAT GIVEN NORMAL FLOW THROUGH THE DISLODGED STENT FRAGMENT AND ITS LOCATION ABOVE THE HYPOGASTRIC ARTERY AND THE COMMON ILIAC ARTERY THAT THE BEST PLAN WOULD BE TO OBSERVE THE PATIENT OVERNIGHT FOR VASCULAR RECOVERY. PULSES AND DOPPLERS WILL BE CHECKED IN SERIAL FASHION AND IF HE MAINTAINS GOOD PERFUSION, THE STENT FRAGMENT WILL REMAIN IN PLACE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT R0408104 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. NO UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. STENT FRACTURES ARE WELL-KNOWN POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. FRACTURE OF SELF-EXPANDING STENTS PLACED IN THE ILIAC ARTERY OCCURS IN APPROXIMATELY 5% OF THE CASES. STENTING IN CHRONIC OCCLUSION REPRESENTS AN INCREASED RISK FACTOR FOR FRACTURE. FRACTURES OF STENTS PLACED IN ILIAC ARTERIES RARELY AFFECT PATENCY. THE ILIAC VESSELS ARE PRONE TO AND UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION DURING MOVEMENT. ILIAC ARTERY CONFORMATION, PARTICULARLY EXTERNAL ILIAC ARTERY (EIA), IS CHANGED BY BENDING OF THE HIP JOINT, SO STENTS PLACED IN ILIAC ARTERIES COULD BE MECHANICALLY STRESSED. SEVERAL MECHANISMS MUST BE CONSIDERED FOR STENT FRACTURE IN THE ILIAC ARTERY. IT HAS BEEN REPORTED THAT THE ILIAC ARTERY, PARTICULARLY EIA, IS EXPOSED TO FLEXION BY BENDING THE HIP JOINT, WHICH SEEMS LIKELY TO BE ASSOCIATED WITH STENT FRACTURE IN ILIAC ARTERIES. IN THIS STUDY, STENT FRACTURE WAS DETECTED IN CIA AS WELL AS EIA. FRACTURE OF STENT PLACED IN CIA MIGHT BE AFFECTED BY THE COMPLEX MOTION INTRODUCED BY THE SPINE IN ADDITION TO THE HIP MOVEMENTS. ANOTHER CAUSE OF STENT FRACTURE MAY BE INTERNAL STRESS ON THE STRUCTURE. A SIGNIFICANT AMOUNT OF INTERNAL STRESS IS CONSIDERED TO BE TRANSMITTED TO THE STENT MATERIAL AS A RESULT OF PULSATILE FLOW. THIS PHENOMENON IS DESCRIBED AS HIGHER IN STENTS PLACED IN THE PULMONARY ARTERY OR AORTA. HOWEVER, WHETHER THE ILIAC ARTERY CAN BE AFFECTED BY PULSATILE BLOOD FLOW AS IN GREAT VESSELS HAS NOT BEEN ESTABLISHED. IN THIS CASE, VESSEL/LESION CHARACTERISTICS, PROCEDURAL FACTORS AND/OR BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT.
THE (B)(6) PATIENT RECEIVED A 8 X 18MM PALMAZ GENESIS STENT IN THE LEFT COMMON ILIAC ARTERY. THREE MONTHS AFTER THE PROCEDURE, THE PREVIOUSLY IMPLANTED GENESIS STENT HAD FRACTURED AND SEPARATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALMAZ GENESIS 8 X 18, 80CM | ENDOVASCULAR SDS/STENTS (FGE) | FGE | CORDIS EUROPA, N.V. | NA | R0408104 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | GLIDEWIRE, 6F DESTINATION SHEATH |