PRECISE SDS SELF EXPANDING
Report
- Report Number
- 9616099-2014-00440
- Event Type
- Injury
- Date Received
- July 1, 2014
- Date of Event
- October 1, 2010
- Report Date
- June 10, 2014
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- FGE
- PMA / PMN Number
- K012993
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
EVENT DESCRIPTION CONTINUED: AFTER THE PULSE RATE WAS INCREASED BY IV ADMINISTRATION OF 0.5MG ATROPINE IN 1ML OF SALINE, THE TARGET LESION WAS PREDILATED WITH 3.4- TO 4.0-MM-DIAMETER ANGIOPLASTY BALLOONS. PRECISE SELF-EXPANDING STENTS WERE IMPLANTED, COVERING THE CAROTID BIFURCATION. ALL STENTS WERE POSTDILATED WITH 4.5- TO 6.0-MM-DIAMETER BALLOONS AT 10 ATMOSPHERES. AFTER POSTDILATION, AN ASPIRATION METHOD WAS ROUTINELY PERFORMED IN EVERY CASE REGARDLESS OF THE ANGIOGRAPHIC FLOW STATE. A 7-F ELIMINATE ASPIRATION CATHETER OR A 7-F THROMBUSTER 3 CATHETER WITH A 30-ML VACUUM SYRINGE WAS ADVANCED TOWARD THE FILTER; BOTH CATHETERS HAD DISTAL TIP DIAMETERS OF 1.25MM. THE TIP OF THE ASPIRATION CATHETER WAS LOCATED JUST PROXIMAL TO THE ANGIOGUARD XP. APPROXIMATELY 20ML OF BLOOD WAS ASPIRATED AND THEN PASSED THROUGH A CELL STRAINER. THE OPERATOR INSPECTED THE CELL STRAINER TO EVALUATE THE MACROSCOPIC DEBRIS PRESENT. THIS PROCEDURE WAS REPEATED AT LEAST 5 TIMES OR UNTIL ALMOST NO DEBRIS WAS OBSERVED MACROSCOPICALLY IN THE CELL STRAINER. FINALLY, A RETRIEVAL SHEATH WAS ADVANCED, AND THE FILTER WAS CLOSED AND REMOVED FROM THE ARTERY. THE REPEATED BLOOD ASPIRATIONS TOOK 3 TO 5 MINUTES FROM POSTDILATION TO THE REMOVAL OF THE FILTER. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: FILTER DEVICE PLACEMENT, PREDILATION, STENT PLACEMENT, POSTDILATION, ASPIRATION OF THE BLOOD COLUMN, AND FILTER RETRIEVAL. THE OPERATORS CLASSIFIED BLOOD FLOW IMMEDIATELY BEFORE FILTER RETRIEVAL AS NORMAL, SLOW, OR STOPPED. STOPPED FLOW WAS DEFINED AS ANTEGRADE FLOW CESSATION, WHILE SLOW FLOW WAS DEFINED AS NEW AND DEFINITE FLOW IMPAIRMENT COMPARED WITH THE FLOW IN THE EXTERNAL CAROTID ARTERY. IN ADDITION TO PROSPECTIVE DATA COLLECTION ON THE INCIDENCE OF FLOW IMPAIRMENT, ALL ANGIOGRAMS WERE REVIEWED RETROSPECTIVELY BY THE EXPERIENCED INTERVENTIONISTS TO QUALITATIVELY ASSESS FLOW IN THE ICA. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. THE CITATION IS AS FOLLOWS: SORIMACHI, T ET AL. (2010, OCTOBER). OBSTRUCTION OF PORES IN DISTAL PROTECTION FILTERS AND ANGIOGRAPHICALLY-DOCUMENTED FLOW IMPAIRMENT DURING CAROTID ARTERY STENTING, J ENDOVASC THERAPY, 17, 661-670. THE EXACT DATE OF PUBLICATION IS UNKNOWN; THEREFORE, THE EVENT DATE WAS PROVIDED AS 10/01/2010. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 1016427-2014-00073 & 9616099-2014-00440. CONCOMITANT MEDICATIONS: HEPARIN AND ATROPINE WERE GIVEN DURING THE PROCEDURE. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN, CLOPIDOGREL AND/OR CILOSTAZOL. THIS IS THE INITIAL AND FINAL REPORT FOR THIS DEVICE. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY SORIMACHI ET AL OBSTRUCTION OF PORES IN DISTAL PROTECTION FILTERS AND ANGIOGRAPHICALLY-DOCUMENTED FLOW IMPAIRMENT DURING CAROTID ARTERY STENTING, J ENDOVASC THERAPY 17 (2010) 661-670; IN ONE-SLOW FLOW CASE, A MINOR STROKE WAS CAUSED BY AN EMBOLIC COMPLICATION DURING THE PROCEDURE. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE ANY RELATIONSHIP BETWEEN ANGIOGRAPHICALLY DOCUMENTED FLOW IMPAIRMENT ASSOCIATED WITH THE ANGIOGUARD XP CEREBRAL PROTECTION FILTER DURING CAROTID ARTERY STENTING (CAS) AND THE CONDITION OF THE PORES IN THE RETRIEVED FILTER. ANGIOGUARD XP FILTERS WERE RETRIEVED FROM 54 CONSECUTIVE PATIENTS (50 MEN; MEAN AGE WAS 71 YEARS, RANGE 53-83) WHO UNDERWENT 56 FILTER-PROTECTED CAS PROCEDURES (2 BILATERAL) UNDER AN APPROVED TREATMENT PROTOCOL. CAS WAS OFFERED TO PATIENTS WITH AN ASYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 80% OR A SYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 50% PATIENTS WITH A HISTORY OF A DISABLING STROKE WERE NOT ELIGIBLE FOR CAS. IN THIS COHORT, 39 LESIONS WERE SYMPTOMATIC AND 17 LESIONS WERE ASYMPTOMATIC. THE CAROTID ARTERY STENOSIS, WHICH AVERAGED 76.1% (RANGE 50%-99%), WAS LOCATED ON THE RIGHT IN 27 CASES AND ON THE LEFT IN 29. ANTIPLATELET THERAPY CONSISTING OF ASPIRIN (100MG/D) AND CLOPIDOGREL (75MG/D) OR CILOSTAZOL (200 MG/D) WAS STARTED AT LEAST 5 DAYS BEFORE THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED USING HAND-INJECTED IOXAGLIC ACID AS THE CONTRAST MEDIUM. DSA IMAGES (3 FRAMES/S) WERE OBTAINED ON THE AXION ARTIS SYSTEM. PERCUTANEOUS ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. HEPARIN WAS GIVEN IV TO MAINTAIN AN ACTIVATED CLOTTING TIME (ACT) >2 TIMES BASELINE, WITH A TARGET OF AT LEAST 300 SECONDS. STENOSES WERE CROSSED WITH 5-,6-, OR 7-MM-DIAMETER ANGIOGUARD XP FILTERS SELECTED TO BE 0.5 TO 1.5MM LARGER THAN THE DISTAL VESSEL DIAMETER AS MEASURED ON DSA. AFTER THE PULSE RATE WAS INCREASED BY IV ADMINISTRATION OF 0.5MG ATROPINE IN 1ML OF SALINE, THE TARGET LESION WAS PREDILATED WITH 3.4- TO 4.0-MM-DIAMETER ANGIOPLASTY BALLOONS. PRECISE SELF-EXPANDING STENTS WERE IMPLANTED, COVERING THE CAROTID BIFURCATION. ALL STENTS WERE POSTDILATED WITH 4.5- TO 6.0-MM-DIAMETER BALLOONS AT 10 ATMOSPHERES. AFTER POSTDILATION, AN ASPIRATION METHOD WAS ROUTINELY PERFORMED IN EVERY CASE REGARDLESS OF THE ANGIOGRAPHIC FLOW STATE. A 7-F ELIMINATE ASPIRATION CATHETER OR A 7-F THROMBUSTER 3 CATHETER WITH A 30-ML VACUUM SYRINGE WAS ADVANCED TOWARD THE FILTER; BOTH CATHETERS HAD DISTAL TIP DIAMETERS OF 1.25MM. THE TIP OF THE ASPIRATION CATHETER WAS LOCATED JUST PROXIMAL TO THE ANGIOGUARD XP. APPROXIMATELY 20ML OF BLOOD WAS ASPIRATED AND THEN PASSED THROUGH A CELL STRAINER. THE OPERATOR INSPECTED THE CELL STRAINER TO EVALUATE THE MACROSCOPIC DEBRIS PRESENT. THIS PROCEDURE WAS REPEATED AT LEAST 5 TIMES OR UNTIL ALMOST NO DEBRIS WAS OBSERVED MACROSCOPICALLY IN THE CELL STRAINER. FINALLY, A RETRIEVAL SHEATH WAS ADVANCED, AND THE FILTER WAS CLOSED AND REMOVED FROM THE ARTERY. THE REPEATED BLOOD ASPIRATIONS TOOK 3 TO 5 MINUTES FROM POSTDILATION TO THE REMOVAL OF THE FILTER. ANGIOGRAPHY WAS SYSTEMATICALLY PERFORMED TO ASSESS FLOW AFTER EACH STEP OF THE PROCEDURE: FILTER DEVICE PLACEMENT, PREDILATION, STENT PLACEMENT, POSTDILATION, ASPIRATION OF THE BLOOD COLUMN, AND FILTER RETRIEVAL. THE OPERATORS CLASSIFIED BLOOD FLOW IMMEDIATELY BEFORE FILTER RETRIEVAL AS NORMAL, SLOW, OR STOPPED. STOPPED FLOW WAS DEFINED AS ANTEGRADE FLOW CESSATION, WHILE SLOW FLOW WAS DEFINED AS NEW AND DEFINITE FLOW IMPAIRMENT COMPARED WITH THE FLOW IN THE EXTERNAL CAROTID ARTERY. IN ADDITION TO PROSPECTIVE DATA COLLECTION ON THE INCIDENCE OF FLOW IMPAIRMENT, ALL ANGIOGRAMS WERE REVIEWED RETROSPECTIVELY BY THE EXPERIENCED INTERVENTIONISTS TO QUALITATIVELY ASSESS FLOW IN THE ICA. NO FURTHER INFORMATION COULD BE OBTAINED. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. HYPOPERFUSION IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. THE HEMODYNAMIC INSTABILITY THAT OCCURS BOTH DURING AND AFTER CAROTID STENT IMPLANTATION IS INFLUENCED BY THE BARO-RECEPTORS, WHICH ARE LOCATED AT THE CAROTID BIFURCATION. THESE BARO-RECEPTORS ARE STIMULATED BY THE STRETCH OF INTERVENTIONAL BALLOONS, SDS (STENT DELIVERY SYSTEM) AND DISTAL PROTECTION DEVICES, INITIATING A REFLEX VIA THE GLOSSOPHARYNGEAL NERVE. THIS RESULTS IN A FALL IN BLOOD PRESSURE AND BRADYCARDIA. STENT PLACEMENT MAY PROMOTE PERSISTENT STIMULATION OF THESE BARO-RECEPTORS. THESE REACTIONS ARE ANTICIPATED RELATIVELY SHORT-TERM ADVERSE EVENTS ASSOCIATED WITH THE COMPRESSION OF THE BARO-RECEPTORS DURING BALLOON INFLATION, STENT IMPLANTATION AND FILTER DEVICE MANIPULATION. CERTAIN FACTORS MAY INFLUENCE THE LIKELIHOOD OF ANTICIPATED BARO-RECEPTOR REACTIONS SUCH AS ADVANCED AGE, VENTRICULAR DYSFUNCTION AND GENDER. A STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT EXPANSION OR POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). THE PHYSICAL MANIPULATION OF THE CAROTID ARTERIES PRODUCES THE RISK OF DISLODGEMENT OF DEBRIS THAT MAY TRAVEL UPSTREAM TO THE CEREBRAL ARTERIES POTENTIALLY DISRUPTING PERFUSION. THIS ACT, INHERENT TO THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A BLOOD VESSEL THAT IS NOT BLOCKED, BUT IS EXTREMELY NARROWED, CAN ALSO CAUSE AN ISCHEMIC STROKE. THE BLOCKED OR NARROWED ARTERIES DEPRIVE BRAIN CELLS OF OXYGEN AND NUTRIENTS, LEADING TO NERVE CELL DEATH. 80% OF ALL STROKES ARE ISCHEMIC. DURING ISCHEMIC STROKE, DIMINISHED BLOOD FLOW INITIATES A SERIES OF EVENTS (CALLED ISCHEMIC CASCADE) THAT MAY RESULT IN ADDITIONAL, DELAYED DAMAGE TO BRAIN CELLS. EARLY MEDICAL INTERVENTION CAN HALT THIS PROCESS AND REDUCE THE RISK FOR IRREVERSIBLE COMPLICATIONS. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENTS. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE EVENTS REPORTED DO NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.
AS NOTED IN THE PUBLICATION BY SORIMACHI ET AL OBSTRUCTION OF PORES IN DISTAL PROTECTION FILTERS AND ANGIOGRAPHICALLY-DOCUMENTED FLOW IMPAIRMENT DURING CAROTID ARTERY STENTING, J ENDOVASC THERAPY 17 (2010) 661-670; IN ONE-SLOW FLOW CASE, A MINOR STROKE WAS CAUSED BY AN EMBOLIC COMPLICATION DURING THE PROCEDURE. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO DETERMINE ANY RELATIONSHIP BETWEEN ANGIOGRAPHICALLY DOCUMENTED FLOW IMPAIRMENT ASSOCIATED WITH THE ANGIOGUARD XP CEREBRAL PROTECTION FILTER DURING CAROTID ARTERY STENTING (CAS) AND THE CONDITION OF THE PORES IN THE RETRIEVED FILTER. ANGIOGUARD XP FILTERS WERE RETRIEVED FROM 54 CONSECUTIVE PATIENTS (50 MEN; MEAN AGE WAS 71 YEARS, RANGE 53-83) WHO UNDERWENT 56 FILTER-PROTECTED CAS PROCEDURES (2 BILATERAL) UNDER AN APPROVED TREATMENT PROTOCOL. CAS WAS OFFERED TO PATIENTS WITH AN ASYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 80% OR A SYMPTOMATIC CAROTID ARTERY STENOSIS GREATER THAN OR EQUAL TO 50% PATIENTS WITH A HISTORY OF A DISABLING STROKE WERE NOT ELIGIBLE FOR CAS. IN THIS COHORT, 39 LESIONS WERE SYMPTOMATIC AND 17 LESIONS WERE ASYMPTOMATIC. THE CAROTID ARTERY STENOSIS, WHICH AVERAGED 76.1% (RANGE 50%-99%), WAS LOCATED ON THE RIGHT IN 27 CASES AND ON THE LEFT IN 29. ANTIPLATELET THERAPY CONSISTING OF ASPIRIN (100MG/D) AND CLOPIDOGREL (75MG/D) OR CILOSTAZOL (200 MG/D) WAS STARTED AT LEAST 5 DAYS BEFORE THE PROCEDURE. ANGIOGRAPHY WAS PERFORMED USING HAND-INJECTED IOXAGLIC ACID AS THE CONTRAST MEDIUM. DSA IMAGES (3 FRAMES/S) WERE OBTAINED ON THE AXION ARTIS SYSTEM. PERCUTANEOUS ACCESS WAS GAINED THROUGH THE FEMORAL ARTERY. HEPARIN WAS GIVEN IV TO MAINTAIN AN ACTIVATED CLOTTING TIME (ACT) >2 TIMES BASELINE, WITH A TARGET OF AT LEAST 300 SECONDS. STENOSES WERE CROSSED WITH 5-,6-, OR 7-MM-DIAMETER ANGIOGUARD XP FILTERS SELECTED TO BE 0.5 TO 1.5MM LARGER THAN THE DISTAL VESSEL DIAMETER AS MEASURED ON DSA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384253 | PRECISE SDS SELF EXPANDING | SELF EXPANDING STENTS (FGE) | FGE | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R| S | ANGIOGUARD EMBOLIC PROTECTION DEVICE |