STENT CORONARY

Report

Report Number: 9616099-2013-00295
Event Type: Injury
Date Received: May 14, 2013
Date of Event: November 1, 2003
Report Date: April 19, 2013
Manufacturer: CORDIS DE MEXICO
Product Code: MAF
PMA / PMN Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PLEASE NOTE THAT THERE ARE 4 EVENTS FOR ARTERIAL STENOSIS ASSOCIATED WITH THIS REPORT. THE ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THE PALMAZ STENT. THE CITATION IS AS FOLLOWS: BAJWA ET AL ENDOVASCULAR INTERVENTION OF AORTOILIAC OCCLUSIVE DISEASE IN HIGH-RISK PATIENTS USING THE KISSING STENTS TECHNIQUE: LONG-TERM RESULTS; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 60:320-326 (2003); LITERATURE REVIEW ARTICLE. BAJWA ET AL ENDOVASCULAR INTERVENTION OF AORTOILIAC OCCLUSIVE DISEASE IN HIGH-RISK PATIENTS USING THE KISSING STENTS TECHNIQUE: LONG-TERM RESULTS; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 60:320-326 (2003); REPORT THAT PALMAZ SHATZ, CORINTHIAN, SMART CONTROL OR PRECISE STENTS WERE USED AND AFTER 20 _ 12.3 MONTHS OF CLINICAL FOLLOW-UP, SIX PATIENTS HAD RECURRENT LIFESTYLE-LIMITING CLAUDICATION THAT WARRANTED AN ANGIOGRAM, OF WHICH TWO PATIENTS HAD PATENT STENTS AT THE AORTOILIAC JUNCTION. BOTH PATIENTS, HOWEVER, HAD SEVERE STENOSIS OF THE SUPERFICIAL FEMORAL ARTERY. FOUR PATIENTS (8%) HAD IN-STENT RESTENOSIS (ONE DISTAL ABDOMINAL AORTA, ONE RIGHT COMMON ILIAC ARTERY, ONE LEFT COMMON ILIAC ARTERY, AND ONE BILATERAL COMMON ILIAC ARTERIES) AND UNDERWENT REPEAT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH EXCELLENT RESULTS. THE PATIENT WITH BILATERAL IN-STENT RESTENOSIS REQUIRED ADDITIONAL STENT DEPLOYMENTS USING A KISSING STENTS TECHNIQUE AND WAS FREE OF CLAUDICATION AFTER 10 MONTHS OF FOLLOW-UP. ONE PATIENT CONTINUED TO HAVE LIFESTYLE-LIMITING CLAUDICATION OF THE RIGHT TOES SECONDARY TO SEVERE DISEASE OF THE DISTAL VESSELS. ACUTE COMPLICATIONS INCLUDED ONE DISSECTION THAT WAS REPAIRED WITH ADDITIONAL STENTS. TWO PATIENTS HAD DISTAL EMBOLI (EXTERNAL ILIAC AND SUPERFICIAL FEMORAL ARTERY; TABLE III). BOTH PATIENTS HAD EVIDENCE OF CLOT PRIOR TO ENDOVASCULAR INTERVENTION AND HAD UNDERGONE THROMBOLYTIC TREATMENT PRIOR TO ENDOVASCULAR INTERVENTION. THE PATIENT WHO HAD EMBOLIZATION TO THE EXTERNAL ILIAC ARTERY WAS TREATED WITH CATHETER-BASED THROMBECTOMY USING AN OASIS THROMBECTOMY SYSTEM (BOSTON SCIENTIFIC). THE OTHER PATIENT REQUIRED SURGICAL EMBOLECTOMY. MINOR ACCESS-RELATED COMPLICATIONS OCCURRED IN THREE PATIENTS, WHICH INCLUDED HEMATOMA FORMATION THAT WAS TREATED WITH LOCAL COMPRESSION AND PROLONGED BED REST. CORDIS 40CM LONG 8F ARTERIAL SHEATHS WERE USED IN ALL CASES. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. COMPLICATIONS REPORTEDLY OCCUR IN APPROXIMATELY 9.9% OF ILIAC ARTERY STENT PLACEMENTS AND INCLUDE THROMBOSIS, DISSECTION, DISTAL EMBOLI, AND HEMATOMA OR PSEUDOANEURYSM FORMATION AT THE PUNCTURE SITE. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. STENOSIS IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN PATIENT FACTOR FOR STENT IMPLANTATION. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. STENOSES ARE USUALLY TREATED WITH PTA OR PLACEMENT OF A STENT. FACTORS THAT MAY HAVE INFLUENCED THESE EVENTS INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND VESSEL / LESION CHARACTERISTICS. HEMATOMA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL INVASIVE PROCEDURES AND IS LISTED IN THE IFU AS SUCH. WHEN ACCESS IS MADE INTO THE VASCULATURE, ESPECIALLY THE ARTERIAL SYSTEM, IT IS POSSIBLE FOR BLOOD TO LEAK AROUND THE DEVICES PLACED INTO THE VESSEL PRODUCING A COLLECTION OF BLOOD WITHIN THE SURROUNDING TISSUE, THUS CREATING A HEMATOMA. THIS OCCURRENCE IS OFTEN ASSOCIATED WITH DEVICE SELECTION, PATIENT ANATOMY AND PRACTITIONER EXPERTISE. CLAUDICATION IS PAIN CAUSED BY TOO LITTLE BLOOD FLOW DURING EXERCISE. SOMETIMES CALLED INTERMITTENT CLAUDICATION, THIS CONDITION GENERALLY AFFECTS THE BLOOD VESSELS IN THE LEGS, BUT CLAUDICATION CAN AFFECT THE ARMS. ALTHOUGH IT'S SOMETIMES CONSIDERED A DISEASE, CLAUDICATION IS TECHNICALLY A SYMPTOM OF A DISEASE. MOST OFTEN, CLAUDICATION IS A SYMPTOM OF PERIPHERAL ARTERY DISEASE, A POTENTIALLY SERIOUS, BUT TREATABLE CIRCULATION PROBLEM. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES OR DEVICE MALFUNCTIONS THAT CONTRIBUTED TO THE REPORTED EVENTS. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. 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. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2013-00296 AND 9616099-2013-00297.

Additional Manufacturer Narrative · 1

PLEASE NOTE THAT THERE ARE 4 EVENTS FOR ARTERIAL STENOSIS ASSOCIATED WITH THIS REPORT. THE ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THE PALMAZ STENT. THE CITATION IS AS FOLLOWS: BAJWA ET AL ENDOVASCULAR INTERVENTION OF AORTOILIAC OCCLUSIVE DISEASE IN HIGH-RISK PATIENTS USING THE KISSING STENTS TECHNIQUE: LONG-TERM RESULTS; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 60:320-326 (2003); LITERATURE REVIEW ARTICLE. BAJWA ET AL ENDOVASCULAR INTERVENTION OF AORTOILIAC OCCLUSIVE DISEASE IN HIGH-RISK PATIENTS USING THE KISSING STENTS TECHNIQUE: LONG-TERM RESULTS; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 60:320-326 (2003); REPORT THAT PALMAZ SHATZ, CORINTHIAN, SMART CONTROL OR PRECISE STENTS WERE USED AND AFTER 20 _ 12.3 MONTHS OF CLINICAL FOLLOW-UP, SIX PATIENTS HAD RECURRENT LIFESTYLE-LIMITING CLAUDICATION THAT WARRANTED AN ANGIOGRAM, OF WHICH TWO PATIENTS HAD PATENT STENTS AT THE AORTOILIAC JUNCTION. BOTH PATIENTS, HOWEVER, HAD SEVERE STENOSIS OF THE SUPERFICIAL FEMORAL ARTERY. FOUR PATIENTS (8%) HAD IN-STENT RESTENOSIS (ONE DISTAL ABDOMINAL AORTA, ONE RIGHT COMMON ILIAC ARTERY, ONE LEFT COMMON ILIAC ARTERY, AND ONE BILATERAL COMMON ILIAC ARTERIES) AND UNDERWENT REPEAT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH EXCELLENT RESULTS. THE PATIENT WITH BILATERAL IN-STENT RESTENOSIS REQUIRED ADDITIONAL STENT DEPLOYMENTS USING A KISSING STENTS TECHNIQUE AND WAS FREE OF CLAUDICATION AFTER 10 MONTHS OF FOLLOW-UP. ONE PATIENT CONTINUED TO HAVE LIFESTYLE-LIMITING CLAUDICATION OF THE RIGHT TOES SECONDARY TO SEVERE DISEASE OF THE DISTAL VESSELS. ACUTE COMPLICATIONS INCLUDED ONE DISSECTION THAT WAS REPAIRED WITH ADDITIONAL STENTS. TWO PATIENTS HAD DISTAL EMBOLI (EXTERNAL ILIAC AND SUPERFICIAL FEMORAL ARTERY; TABLE III). BOTH PATIENTS HAD EVIDENCE OF CLOT PRIOR TO ENDOVASCULAR INTERVENTION AND HAD UNDERGONE THROMBOLYTIC TREATMENT PRIOR TO ENDOVASCULAR INTERVENTION. THE PATIENT WHO HAD EMBOLIZATION TO THE EXTERNAL ILIAC ARTERY WAS TREATED WITH CATHETER-BASED THROMBECTOMY USING AN OASIS THROMBECTOMY SYSTEM (BOSTON SCIENTIFIC). THE OTHER PATIENT REQUIRED SURGICAL EMBOLECTOMY. MINOR ACCESS-RELATED COMPLICATIONS OCCURRED IN THREE PATIENTS, WHICH INCLUDED HEMATOMA FORMATION THAT WAS TREATED WITH LOCAL COMPRESSION AND PROLONGED BED REST. CORDIS 40CM LONG 8F ARTERIAL SHEATHS WERE USED IN ALL CASES. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. COMPLICATIONS REPORTEDLY OCCUR IN APPROXIMATELY 9.9% OF ILIAC ARTERY STENT PLACEMENTS AND INCLUDE THROMBOSIS, DISSECTION, DISTAL EMBOLI, AND HEMATOMA OR PSEUDOANEURYSM FORMATION AT THE PUNCTURE SITE. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. VESSELS THAT ARE RESISTANT TO ANGIOPLASTY HAVE A HIGHER RISK OF INTIMAL DISSECTION DURING INTERVENTIONAL PROCEDURES. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. STENOSIS IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN PATIENT FACTOR FOR STENT IMPLANTATION. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. STENOSES ARE USUALLY TREATED WITH PTA OR PLACEMENT OF A STENT. FACTORS THAT MAY HAVE INFLUENCED THESE EVENTS INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND VESSEL / LESION CHARACTERISTICS. HEMATOMA IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL INVASIVE PROCEDURES AND IS LISTED IN THE IFU AS SUCH. WHEN ACCESS IS MADE INTO THE VASCULATURE, ESPECIALLY THE ARTERIAL SYSTEM, IT IS POSSIBLE FOR BLOOD TO LEAK AROUND THE DEVICES PLACED INTO THE VESSEL PRODUCING A COLLECTION OF BLOOD WITHIN THE SURROUNDING TISSUE, THUS CREATING A HEMATOMA. THIS OCCURRENCE IS OFTEN ASSOCIATED WITH DEVICE SELECTION, PATIENT ANATOMY AND PRACTITIONER EXPERTISE. CLAUDICATION IS PAIN CAUSED BY TOO LITTLE BLOOD FLOW DURING EXERCISE. SOMETIMES CALLED INTERMITTENT CLAUDICATION, THIS CONDITION GENERALLY AFFECTS THE BLOOD VESSELS IN THE LEGS, BUT CLAUDICATION CAN AFFECT THE ARMS. ALTHOUGH IT'S SOMETIMES CONSIDERED A DISEASE, CLAUDICATION IS TECHNICALLY A SYMPTOM OF A DISEASE. MOST OFTEN, CLAUDICATION IS A SYMPTOM OF PERIPHERAL ARTERY DISEASE, A POTENTIALLY SERIOUS, BUT TREATABLE CIRCULATION PROBLEM. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES OR DEVICE MALFUNCTIONS THAT CONTRIBUTED TO THE REPORTED EVENTS. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. 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. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2013-00296 AND 9616099-2013-00297.

Description of Event or Problem · 1

BAJWA ET AL ENDOVASCULAR INTERVENTION OF AORTOILIAC OCCLUSIVE DISEASE IN HIGH-RISK PATIENTS USING THE KISSING STENTS TECHNIQUE: LONG-TERM RESULTS; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 60:320-326 (2003); REPORT THAT PALMAZ SHATZ, CORINTHIAN, SMART CONTROL OR PRECISE STENTS WERE USED AND AFTER 20 _ 12.3 MONTHS OF CLINICAL FOLLOW-UP, SIX PATIENTS HAD RECURRENT LIFESTYLE-LIMITING CLAUDICATION THAT WARRANTED AN ANGIOGRAM, OF WHICH TWO PATIENTS HAD PATENT STENTS AT THE AORTOILIAC JUNCTION. BOTH PATIENTS, HOWEVER, HAD SEVERE STENOSIS OF THE SUPERFICIAL FEMORAL ARTERY. FOUR PATIENTS (8%) HAD IN-STENT RESTENOSIS (ONE DISTAL ABDOMINAL AORTA, ONE RIGHT COMMON ILIAC ARTERY, ONE LEFT COMMON ILIAC ARTERY, AND ONE BILATERAL COMMON ILIAC ARTERIES) AND UNDERWENT REPEAT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WITH EXCELLENT RESULTS. THE PATIENT WITH BILATERAL IN-STENT RESTENOSIS REQUIRED ADDITIONAL STENT DEPLOYMENTS USING A KISSING STENTS TECHNIQUE AND WAS FREE OF CLAUDICATION AFTER 10 MONTHS OF FOLLOW-UP. ONE PATIENT CONTINUED TO HAVE LIFESTYLE-LIMITING CLAUDICATION OF THE RIGHT TOES SECONDARY TO SEVERE DISEASE OF THE DISTAL VESSELS. ACUTE COMPLICATIONS INCLUDED ONE DISSECTION THAT WAS REPAIRED WITH ADDITIONAL STENTS. TWO PATIENTS HAD DISTAL EMBOLI (EXTERNAL ILIAC AND SUPERFICIAL FEMORAL ARTERY; TABLE III). BOTH PATIENTS HAD EVIDENCE OF CLOT PRIOR TO ENDOVASCULAR INTERVENTION AND HAD UNDERGONE THROMBOLYTIC TREATMENT PRIOR TO ENDOVASCULAR INTERVENTION. THE PATIENT WHO HAD EMBOLIZATION TO THE EXTERNAL ILIAC ARTERY WAS TREATED WITH CATHETER-BASED THROMBECTOMY USING AN OASIS THROMBECTOMY SYSTEM (BOSTON SCIENTIFIC). THE OTHER PATIENT REQUIRED SURGICAL EMBOLECTOMY. MINOR ACCESS-RELATED COMPLICATIONS OCCURRED IN THREE PATIENTS, WHICH INCLUDED HEMATOMA FORMATION THAT WAS TREATED WITH LOCAL COMPRESSION AND PROLONGED BED REST. CORDIS 40CM LONG 8F ARTERIAL SHEATHS WERE USED IN ALL CASES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
212268	STENT CORONARY	CORONARY SDS/STENTS	MAF	CORDIS DE MEXICO	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1