PALMAZ GENESIS UNKNOWN

Report

Report Number: 9610978-2011-00065
Event Type: Injury
Date Received: April 4, 2011
Date of Event: January 1, 2011
Report Date: May 12, 2011
Manufacturer: CORDIS EUROPA, N.V.
Product Code: FGE
PMA / PMN Number: UNK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

JOURNAL ARTICLE: TANAKA, AKIHITO ET AL IN MIGRATION OF FRACTURED RENAL ARTERY STENT, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 77:305-307 (2011). THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

Additional Manufacturer Narrative · 1

TANAKA ET AL IN MIGRATION OF FRACTURED RENAL ARTERY STENT, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 77:305-307 (2011); REPORT THE FOLLOWING: A (B)(6) MAN WITH UNCONTROLLED HYPERTENSION WAS ADMITTED WITH AN ACUTE EXACERBATION OF HEART FAILURE. HE HAD RENAL INSUFFICIENCY, PERIPHERAL ARTERY DISEASE AND A PREVIOUS FEMOROPOPLITEAL BYPASS OPERATION. A DOPPLER ULTRASOUND STUDY SUGGESTED SEVERE NARROWING OF THE RIGHT RENAL ARTERY. THE ARTERY WAS TORTUOUS WITH A 99% STENOSIS, WHICH WAS SUCCESSFULLY DILATED BY STENT IMPLANTATION WITH A PALMAZ GENESIS 5 X 18 MM STENT AT 6ATM. IVUS WAS NOT DONE AFTER THE INITIAL STENT PLACEMENT. THE STENT WAS POST DILATED WITH A 4MM BALLOON AT 6TAM FOR 10 SECONDS. THE PROXIMAL EDGE OF THE STENT WAS EXACTLY POSITIONED AT THE OSTIUM OF THE RENAL ARTERY. THE FOLLOW-UP ANGIOGRAPHY TAKEN 6 MONTHS LATER SHOWED A COMPLETE TRANSVERSE STENT FRACTURE WITHOUT RESTENOSIS. THE PROXIMAL PART OF THE STENT WAS DISLOCATED AND PROTRUDED INTO THE AORTA. THE ULTRASOUND EXAMINATION TAKEN 3 YEARS LATER SHOWED THE ACCELERATION OF THE RIGHT RENAL ARTERY FLOW. RENAL ANGIOGRAPHY SHOWED THE COMPLETE MIGRATION OF THE PROXIMAL PART OF THE FRACTURED STENT TO THE AORTIC WALL OF THE INFRARENAL AORTA. A CT IMAGE SHOWED THAT THE MIGRATED STENT WAS COMPLETELY STUCK INTO THE AORTIC WALL. THE PATIENT'S CLINICAL CONDITION HAS BEEN STABLE WITHOUT ANY FURTHER PROCEDURES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. PERCUTANEOUS RENAL ARTERY STENTING HAS BECOME THE TREATMENT OF CHOICE FOR OSTIAL ATHEROSCLEROTIC RENAL ARTERY STENOSIS. IN-STENT RESTENOSIS (ISR) STILL REMAINS A PERSISTENT PROBLEM BECAUSE ATHEROSCLEROTIC STENOSIS IS A PROGRESSIVE DISEASE. THE INCIDENCE OF ISR AFTER RENAL ARTERY STENTING HAS BEEN REPORTED IN THE LITERATURE TO BE 12 TO 21% AND AS HIGH AS 44% IN ONE SERIES. ADDITIONAL RESEARCH IS NEEDED TO EVALUATE THE BEST TREATMENT METHODS FOR THIS OCCURRENCE. ALTHOUGH THERE IS NO STANDARD TREATMENT METHOD, STENTING SHOWS A REDUCTION IN THE RESTENOSIS RATE COMPARED TO CONVENTIONAL ANGIOPLASTY. PUBLISHED LITERATURE POINTS OUT THAT THERE SEEMS TO BE A SIGNIFICANT RELATION BETWEEN STENT DIAMETER AND LENGTH AND RESTENOSIS. THIS RELATION CONFIRMS THE IMPORTANCE OF CORRECT STENT SELECTION IN INCREASING LONG-TERM PATENCY. STENT FRACTURES ARE WELL-KNOWN POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. ALTHOUGH RARELY REPORTED, STENTS IN RENAL ARTERIES ARE NOT IMMUNE TO FRACTURE. CURRENT LITERATURE SUGGESTS THAT THE MOBILITY OF THE KIDNEY CAN LEAD TO RENAL ARTERY STENT FRACTURE AND ACCELERATED IN-STENT RESTENOSIS. STENT FRACTURES HAVE BEEN OBSERVED IN SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND HIGH RATE OF STENOSIS. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENTS. HOWEVER, THERE ARE POSSIBLE VESSEL CHARACTERISTICS, SUCH AS HIGH DEGREE OF ANGULATION, AS WELL AS PROGRESSION OF ATHEROSCLEROTIC RENAL ARTERY DISEASE THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. IN ADDITION, THERE ARE BIOMECHANICAL FORCES THAT CAN POSSIBLY LEAD TO STRUT FATIGUE AND FRACTURE OF THE STENTS. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND ALTHOUGH A DHR REVIEW COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER, THERE IS NO INDICATION FROM THE INFORMATION AT HAND THAT THESE EVENTS WERE DESIGN OR MANUFACTURING RELATED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Description of Event or Problem · 1

TANAKA ET AL IN MIGRATION OF FRACTURED RENAL ARTERY STENT, CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 77:305-307 (2011); REPORT THE FOLLOWING: A (B)(6) MAN WITH UNCONTROLLED HYPERTENSION WAS ADMITTED WITH AN ACUTE EXACERBATION OF HEART FAILURE. HE HAD RENAL INSUFFICIENCY (SERUM CREATININE LEVEL 1/4 1.6 MG/DL), PERIPHERAL ARTERY DISEASE AND A PREVIOUS FEMOROPOPLITEAL BYPASS OPERATION. A DOPPLER ULTRASOUND STUDY SUGGESTED SEVERE NARROWING OF THE RIGHT RENAL ARTERY. THE RIGHT RENAL ANGIOGRAPHY SHOWED A 99% STENOSIS, WHICH WAS SUCCESSFULLY DILATED BY A STENT IMPLANTATION (PALMATZ GENESIS 5 X 18 MM, CORDIS). THE PROXIMAL EDGE OF THE STENT WAS EXACTLY POSITIONED AT THE OSTIUM OF THE RENAL ARTERY. THE FOLLOW-UP ANGIOGRAPHY TAKEN 6 MONTHS LATER SHOWED A COMPLETE TRANSVERSE STENT FRACTURE WITHOUT RESTENOSIS. THE PROXIMAL PART OF THE STENT WAS DISLOCATED AND PROTRUDED INTO THE AORTA. THE ULTRASOUND EXAMINATION TAKEN 3 YEARS LATER SHOWED THE ACCELERATION OF THE RIGHT RENAL ARTERY FLOW. RENAL ANGIOGRAPHY SHOWED THE COMPLETE MIGRATION OF THE PROXIMAL PART OF THE FRACTURED STENT TO THE AORTIC WALL OF THE INFRARENAL AORTA. A CT IMAGE SHOWED THAT THE MIGRATED STENT WAS COMPLETELY STUCK INTO THE AORTIC WALL. THE PATIENT'S CLINICAL CONDITION HAS BEEN STABLE WITHOUT ANY FURTHER PROCEDURES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PALMAZ GENESIS UNKNOWN	ENDOVASCULAR SDS/STENTS (FGE)	FGE	CORDIS EUROPA, N.V.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Hospitalization