BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM

    MDR report key: 1883780 · Received October 27, 2010

    Report

    Report Number
    1016427-2010-00130
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NTE
    PMA / PMN Number
    K062531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 10 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED DUE TO ALTERED MENTAL STATUS WHICH HAD PROGRESSED OVER THE PAST THREE DAYS. HE DID NOT FOLLOW ANY SIMPLE COMMANDS. A CT SCAN WAS PERFORMED UPON ADMISSION AND SHOWED NO NEW FINDINGS. A FOLLOW-UP CT TWO DAYS LATER SHOWED NO ACUTE ABNORMALITIES. THE PATIENT EXPERIENCED TRANSIENT ISCHEMIC ATTACKS AND UNDERWENT CEREBROVASCULAR DUPLEX THAT REVEALED 1 TO 49% STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY AND 50 TO 69% STENOSIS IN THE LEFT INTERNAL CAROTID ARTERY (INDEX PROCEDURE STENT PLACED IN OSTIAL LEFT INTERNAL CAROTID ARTERY) BY VELOCITY CRITERIA ONLY. THE STENT WAS PATENT BY IMAGING. A CT PERFORMED EIGHTEEN DAYS AFTER ADMISSION SHOWED SUBACUTE INFARCTION OF THE LEFT POSTERIOR FRONTAL LOBE AND RIGHT OCCIPITAL LOBE, AND MULTIPLE FOCI IN THE PARIETAL CENTRUM SEMIOVALE. DISTRIBUTION OF FINDINGS RAISED THE POSSIBILITY OF WATERSHED TYPE INFARCTION. THERE WAS ALSO GYRIFORM ENHANCEMENT INVOLVING THE LEFT POSTERIOR FRONTAL LOBE AND PARIETO-OCCIPITAL, LIKELY RELATED TO SUBACUTE INFARCTION. MRA OF THE NECK REVEALED NORMAL ENHANCEMENT OF THE DISTAL LEFT CERVICAL INTERNAL CAROTID ARTERY AND MILD STENOSIS AT THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY. A CT SCAN PERFORMED APPROXIMATELY 10 DAYS LATER SHOWED FURTHER EVOLUTION OF THE LEFT-SIDED INFARCT MAINLY AFFECTING THE RIGHT PARIETAL OCCIPITAL REGION WITH MULTIPLE OTHER CHRONIC INFARCTIONS BILATERALLY THAT ARE STABLE. DURING HOSPITALIZATION, THE PATIENT HAD DYSPHAGIA DUE TO THE STROKES AND UNDERWENT PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT. HE WAS DISCHARGED TO A REHABILITATION FACILITY APPROXIMATELY 35 DAYS AFTER ADMISSION. THE DISCHARGE SUMMARY STATED THAT THE PATIENT HAD CONFUSION AFTER THE INDEX PROCEDURE, THAT GRADUALLY GOT BETTER, BUT HE HAD ANOTHER STROKE. WHILE HE WAS IN THE HOSPITAL, HE HAD 2 MORE EPISODES OF STROKE. APPROXIMATELY SIX DAYS AFTER DISCHARGE, THE PATIENT EXPIRED. THE DEATH CERTIFICATE LISTED THE CAUSE OF DEATH TO BE COMPLICATIONS OF CVA. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00523 AND 1016427-2010-00130.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA THE (B)(4), AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS MILDLY CALCIFIED, ECCENTRIC, AND 20MM IN LENGTH. THE REFERENCE VESSEL WAS 5MM IN DIAMETER AND MODERATELY TORTUOUS. THE WIRE TIPS OF TWO ANGIOGUARD RX DEVICES WITH 6MM BASKETS BENT DURING USE IN THE PATIENT AND WERE REMOVED WITHOUT INJURY TO THE PATIENT. AN ANGIOGUARD RX WITH A 5MM BASKET WAS DEPLOYED BEYOND THE TARGET LESION. PRE-DILATION OF THE LESION WAS NOT DOCUMENTED. AN 8.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION AND THE ANGIOGUARD DEVICE WAS RETRIEVED WITH NO DEBRIS IN THE FILTER BASKET. THERE WAS NO RESIDUAL STENOSIS AND THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL DEFICIT. ADDITIONAL INFORMATION RECEIVED ON 9/29/2010 INDICATED THAT THE PATIENT EXPERIENCED HYPOTENSION (66/42 MM/HG) THAT WAS TREATED WITH DOPAMINE SUPPORT IN THE EARLY PERIOD FOLLOWING IMPLANTATION OF THE PRECISE STENT. HE ALSO WAS MILDLY CONFUSED AND DISORIENTED. A CT SCAN WAS NEGATIVE AND CAROTID DUPLEX SHOWED A WIDELY PATENT STENT. THE PATIENT WAS DISCHARGED ON CLOPIDOGREL. APPROXIMATELY 10 DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED DUE TO ALTERED MENTAL STATUS WHICH HAD PROGRESSED OVER THE PAST THREE DAYS. HE DID NOT FOLLOW ANY SIMPLE COMMANDS. A CT SCAN WAS PERFORMED UPON ADMISSION AND SHOWED NO NEW FINDINGS. A FOLLOW-UP CT TWO DAYS LATER SHOWED NO ACUTE ABNORMALITIES. THE PATIENT EXPERIENCED TRANSIENT ISCHEMIC ATTACKS AND UNDERWENT CEREBROVASCULAR DUPLEX THAT REVEALED 1 TO 49% STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY AND 50 TO 69% STENOSIS IN THE LEFT INTERNAL CAROTID ARTERY (INDEX PROCEDURE STENT PLACED IN OSTIAL LEFT INTERNAL CAROTID ARTERY) BY VELOCITY CRITERIA ONLY. THE STENT WAS PATENT BY IMAGING. A CT PERFORMED EIGHTEEN DAYS AFTER ADMISSION SHOWED SUBACUTE INFARCTION OF THE LEFT POSTERIOR FRONTAL LOBE AND RIGHT OCCIPITAL LOBE, AND MULTIPLE FOCI IN THE PARIETAL CENTRUM SEMIOVALE. DISTRIBUTION OF FINDINGS RAISED THE POSSIBILITY OF WATERSHED TYPE INFARCTION. THERE WAS ALSO GYRIFORM ENHANCEMENT INVOLVING THE LEFT POSTERIOR FRONTAL LOBE AND PARIETO-OCCIPITAL, LIKELY RELATED TO SUBACUTE INFARCTION. MRA OF THE NECK REVEALED NORMAL ENHANCEMENT OF THE DISTAL LEFT CERVICAL INTERNAL CAROTID ARTERY AND MILD STENOSIS AT THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY. A CT SCAN PERFORMED APPROXIMATELY 10 DAYS LATER SHOWED FURTHER EVOLUTION OF THE LEFT-SIDED INFARCT MAINLY AFFECTING THE RIGHT PARIETAL OCCIPITAL REGION WITH MULTIPLE OTHER CHRONIC INFARCTIONS BILATERALLY THAT ARE STABLE. DURING HOSPITALIZATION, THE PATIENT HAD DYSPHAGIA DUE TO THE STROKES AND UNDERWENT PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE PLACEMENT. HE WAS DISCHARGED TO A REHABILITATION FACILITY APPROXIMATELY 35 DAYS AFTER ADMISSION. THE DISCHARGE SUMMARY STATED THAT THE PATIENT HAD CONFUSION AFTER THE INDEX PROCEDURE, THAT GRADUALLY GOT BETTER, BUT HE HAD ANOTHER STROKE. WHILE HE WAS IN THE HOSPITAL, HE HAD 2 MORE EPISODES OF STROKE. APPROXIMATELY SIX DAYS AFTER DISCHARGE, THE PATIENT EXPIRED. THE DEATH CERTIFICATE LISTED THE CAUSE OF DEATH TO BE COMPLICATIONS OF CVA. 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. ACTION TAKEN: NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HEMODYNAMIC DEPRESSION DURING CAROTID ARTERY STENTING PROCEDURES IS A COMMON EVENT AND IS MOST LIKELY RELATED TO CORONARY SINUS REFLEX OR VAGAL RESPONSE. THE VAGUS NERVE ENTERS THE THORAX BETWEEN COMMON CAROTID ARTERY AND SUBCLAVIAN ARTERY AND DESCENDS DOWNWARD. DURING BALLOON INFLATION OR STENT DEPLOYMENT, PRESSURE CAN BE EXERTED ON THE NERVE STIMULATING A PARASYMPATHETIC RESPONSE, I.E. BRADYCARDIA, HYPOTENSION, HEART BLOCK, ASYSTOLE, ETC. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEFECT OF THE DEVICE, BUT IS LIKELY RELATED TO VESSEL CHARACTERISTICS, PATIENT AND PROCEDURAL FACTORS. CEREBROVASCULAR ACCIDENT IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY AND CAN BE DEFINED AS A CEREBROVASCULAR DISORDER CAUSED BY DEPRIVATION OF BLOOD FLOW TO AN AREA OF THE BRAIN, GENERALLY AS A RESULT OF THROMBOSIS, EMBOLISM, OR REDUCED BLOOD PRESSURE. AS ENDORSED BY 2009 GUIDELINES FROM THE AMERICAN HEART ASSOCIATION AND AMERICAN STROKE ASSOCIATION (AHA/ASA) ISCHEMIC STROKE IS DEFINED AS AN INFRACTION OF CENTRAL NERVOUS SYSTEM TISSUE. 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. EIGHTY PERCENT 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 EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00523 AND 1016427-2010-00130.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) REGISTRY, ANGIOGRAPHY REVEALED 80% STENOSIS OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS DESCRIBED AS MILDLY CALCIFIED, ECCENTRIC, AND 20MM IN LENGTH. THE REFERENCE VESSEL WAS 5MM IN DIAMETER AND MODERATELY TORTUOUS. AN ANGIOGUARD RX WITH A 5MM BASKET WAS DEPLOYED BEYOND THE TARGET LESION. PRE-DILATION OF THE LESION WAS NOT DOCUMENTED. AN 8.0 X 40MM PRECISE PRO RX WAS IMPLANTED AT THE TARGET LESION AND THE ANGIOGUARD DEVICE WAS RETRIEVED WITH NO DEBRIS IN THE FILTER BASKET. THERE WAS NO RESIDUAL STENOSIS. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2010 INDICATED THAT THE PATIENT EXPERIENCED HYPOTENSION (66/42 MM/HG) THAT WAS TREATED WITH DOPAMINE SUPPORT IN THE EARLY PERIOD FOLLOWING IMPLANTATION OF THE PRECISE STENT. HE ALSO WAS MILDLY CONFUSED AND DISORIENTED. A CT SCAN WAS NEGATIVE AND CAROTID DUPLEX SHOWED A WIDELY PATENT STENT. THE PATIENT WAS DISCHARGED ON CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM EMBOLIC PROTECTION DEVICE (NTE) NTE CORDIS CORPORATION 71209508

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention