ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE SYSTEM
Report
- Report Number
- 1016427-2010-00141
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- October 20, 2010
- Report Date
- December 16, 2010
- Manufacturer
- CORDIS CORPORATION
- Product Code
- NTE
- PMA / PMN Number
- K062531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2010-00877. 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.
THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2010-00877THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2010-00877. THE (B)(6) FEMALE PATIENT WAS PART OF THE (B)(4) STUDY. THE PATIENT'S MEDICAL HISTORY INCLUDES SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, CLINICAL COPD, DIABETES MELLITUS AND HYPERTENSION. THE PATIENT RECEIVED A PRECISE STENT IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS NOT CALCIFIED OR TORTUOUS. DURING POST-DILATATION IN THE INDEX PROCEDURE, THE PATIENT HAD APHASIA WHICH WAS DIAGNOSED AS AN ISCHEMIC STROKE. EMERGENT CEA SURGERY WAS PERFORMED. THE PATIENT HAS PARTIALLY RECOVERED WITH MAJOR RESIDUALS. (B)(4) NOTE: LAKE REGION LOT NUMBER 02422901 WHICH IS CORDIS LOT NUMBER 70710505. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 02422901. THIS PACKAGING LOT CONTAINED 101 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON JULY 29, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. SEE ATTACHMENT. (B)(4) 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 15146401 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (B)(4). NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. NO NONCONFORMANCE RECORDS AND EXCURSIONS WERE ISSUED FOR THIS LOT. 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. ISCHEMIC STROKE 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.
THE (B)(6) FEMALE PATIENT WAS PART OF THE (B)(6) STUDY. THE PATIENT'S MEDICAL HISTORY INCLUDES SEVERE PULMONARY DISEASE, HYPERLIPIDEMIA, CLINICAL COPD, DIABETES MELLITUS AND HYPERTENSION. THE PATIENT RECEIVED A PRECISE STENT IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. THE LESION WAS NOT CALCIFIED OR TORTUOUS. DURING POST-DILATATION THE PATIENT HAD APHASIA WHICH WAS DIAGNOSED AS AN ISCHEMIC STROKE AND ALSO EXPERIENCED HYPOTENSION. EMERGENT CEA SURGERY WAS PERFORMED. THE PATIENT HAS PARTIALLY RECOVERED WITH MAJOR RESIDUALS. (B)(4). ISCHEMIC STROKE 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; 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 EVENT. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00877 AND 1016427-2010-00141.
THE ADJUDICATION MINUTES RECEIVED ON (B)(4) 2012 AGREE WITH THE PREVIOUS DIAGNOSIS OF CVA MAJOR, IPSILATERAL, ISCHEMIC/EMBOLIC OCCURRING POST STENT IMPLANTATION AND THAT THE EVENT WAS PROCEDURE AND DEVICE RELATED. THIS INFORMATION DOES NOT CHANGE THE PREVIOUS DETERMINATION. THE CURRENT CODE OF STROKE WILL REMAIN AS A REPORTABLE COMPLAINT. BASED ON THE INFORMATION PROVIDED IN THE ADJUDICATION MINUTES, HYPOTENSION WILL BE CAPTURED AND PROCESSED ACCORDINGLY. PRE-PROCEDURE ON (B)(6) 2010 THE NIH STROKE SCALE SCORE WAS 1 (ATTRIBUTION UNAVAILABLE) AND THE RANKIN STROKE SCALE SCORES WAS 0. ON (B)(6) 2010, SHE UNDERWENT THE INDEX PROCEDURE WITH DELIVERY OF THE ANGIOGUARD RX ECGW, PLACEMENT OF ONE PRECISE PRO RX STENT AND POST-STENT BALLOON ANGIOPLASTY IN THE LEFT PROXIMAL ICA. POST-DILATATION WAS PERFORMED. FOLLOWING THIS, THE PATIENT DEVELOPED NEUROLOGICAL DEFICITS REPORTED AS APHASIA, RIGHT HEMIPARESIS OR HEMIPLEGIA AND RIGHT HEMIATAXIA. THE CATHETERIZATION REPORT NOTED THAT BEFORE REMOVING AND CAPTURING THE FILTER, REPEAT ANGIOGRAM SHOWED NO RESIDUAL IN-LESION STENOSIS, HOWEVER, THE CONTRAST DID NOT GO BEYOND THE ANGIOGUARD RX ECGW FILTER. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS. THE ANGIOGUARD RX ECGW FILTER WAS REMOVED. THE TARGET LESION FORM NOTED THAT DEBRIS WAS FOUND IN THE FILTER BASKET. A FOLLOW-UP CEREBRAL ANGIOGRAPHY SHOWED THE FLOW GOING INTO CEREBRAL BRANCHES, EXCEPT FOR THE MIDDLE CEREBRAL ARTERY. AN AP VIEW CONFIRMED A SUDDEN ABRUPT STOP OF THE FLOW IN THE PROXIMAL MIDDLE CEREBRAL ARTERY. THE CATHETERIZATION REPORT STATED THAT AT THAT TIME THE PATIENT BECAME LESS AWAKE, SLIGHTLY CONFUSED AND WEAKER ON THE RIGHT UPPER AND LOWER EXTREMITIES. SHE WAS ALSO HYPOTENSIVE, AND IV DRIP AND IV BOLUS OF LEVOPHED WERE ADMINISTERED TO KEEP MEAN ARTERIAL PRESSURE ABOVE 85 MMHG. THE INTERVENTION NEUROLOGY RADIOLOGY WAS CONSULTED, AND WHILE STILL IN THE CATHETERIZATION LAB, THE PATIENT WAS ADMINISTERED A BOLUS OF TPA FOLLOWED BY TPA DRIP OVER AN HOUR. THE PATIENT WAS TRANSFERRED TO THE INTERVENTION NEUROLOGY RADIOLOGY DEPARTMENT FOR FURTHER EVALUATION. A BRAIN CT SCAN ON (B)(6) 2010 REVEALED A SMALL AREA OF ACUTE INFARCTION INVOLVING ANTERIOR RIGHT CORONA RADIATA AND REMOTE RELATIVELY SMALL LEFT PARIETAL CORTICAL INFARCTION. THERE WAS NO GROSS HEMORRHAGE WITH A SMALL AMOUNT OF SUBARACHNOID CONTRAST SUSPECTED. THE INTERVENTION NEUROLOGY RADIOLOGY CONSULTATION ON (B)(4) 2010 NOTED THAT PRIOR TO THE TPA TREATMENT, SHE HAD 0/5 STRENGTH IN RIGHT UPPER AND RIGHT LOWER EXTREMITIES AND EXPRESSIVE/RECEPTIVE APHASIA, AND AFTER IV TPA, WHILE ON THE TABLE IN THE CATHETERIZATION LAB, SHE HAD 4/5 STRENGTH IN THE RIGHT UPPER EXTREMITY AND 3-4/5 IN THE RIGHT LOWER EXTREMITY. IN THE INTERVENTION NEUROLOGY RADIOLOGY SUITE, THE PATIENT UNDERWENT DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) UNDER GENERAL ENDOTRACHEAL ANESTHESIA FOR PATIENT'S SAFETY. DSA SHOWED OCCLUSION OF DISTAL M1 IN THE LEFT MCA. AT THIS POINT, ADDITIONAL TREATMENT WITH IA THROMBOLYSIS USING TPA AND ABCIXIMAB AS WELL AS A CLOT DISRUPTION USING PENUMBRA DEVICE WAS PERFORMED. FOLLOW-UP DSA SHOWED IMPROVEMENT OF FLOW INTO THE LEFT MCA, BUT STILL A LARGE PARIETAL CAPILLARY FLOW DEFECT WAS NOTED. AT THIS POINT, THE PROCEDURE ENDED, AND THE PATIENT WAS TRANSFERRED TO THE ICU. THE FOLLOWING DAY, THE PATIENT WAS EXTUBATED. SHE SHOWED SOME NEUROLOGICAL IMPROVEMENT AND DECREASE IN NEUROLOGICAL DEFICITS IN HER RIGHT UPPER AND LOWER EXTREMITIES. A BRAIN CT SCAN ON (B)(4) 2010 REVEALED 1) INTERVAL EVOLUTION OF LEFT MCA DISTRIBUTION INFARCT WITH LARGE AREAS OF CYTOTOXIC EDEMA NOW OBSERVED INVOLVING A MAJORITY OF THE LEFT TEMPORAL AND LEFT PARIETAL LOBES: 2) PERSISTENT LINEAR FOCUS OF HYPERATTENUATION WITHIN THE LEFT SYLVIAN CISTERN, LIKELY REPRESENTS THROMBOSED VESSEL; 3) NO INTRACRANIAL HEMORRHAGE OR BRAIN HERNIATION OBSERVED. ON (B)(6) 2010, SHE DEVELOPED A SEIZURE AND WAS REINTUBATED FOR AIRWAY SAFETY. A BRAIN CT SCAN ON (B)(6) 2010 REVEALED FURTHER EVOLUTIONARY CHANGES OF THE LEFT ACUTE MCA INFARCTION. NO HEMORRHAGE WAS REPORTED. PRIOR TO SEIZURE, SHE COMPLAINED OF ABDOMINAL PAIN, AND THEREFORE CT OF ABDOMEN WAS PERFORMED. IT SHOWED AN INTRA-ABDOMINAL ABSCESS SECONDARY TO RUPTURED VISCUS. IT WAS INDICATED THAT THE ABSCESS "OBVIOUSLY" HAD DEVELOPED PRIOR TO HOSPITALIZATION. SHE UNDERWENT LAPAROSCOPY AND CT-GUIDED DRAINAGE OF INTRA-ABDOMINAL ABSCESS. SECONDARY TO THIS, ON (B)(6) 2010 THE PATIENT UNDERWENT A SMALL BOWEL RESECTION, DRAINAGE OF INTRA-ABDOMINAL ABSCESS AND APPENDECTOMY. SHE DEVELOPED RESPIRATORY FAILURE, FOR WHICH AN OPEN TRACHEOSTOMY ON (B)(6) 2010 WAS PERFORMED. SHE REMAINED VENTILATOR-DEPENDENT THROUGHOUT HER HOSPITAL COURSE. FURTHER, THE PATIENT DEVELOPED RIGHT LOWER EXTREMITY SWELLING AND DUPLEX ULTRASOUND REVEALED DEEP VEIN THROMBOSIS. THE PATIENT WAS STARTED ON HEPARIN DRIP. DUE TO INTRA-ABDOMINAL ABSCESS, SHE WAS ON MULTIPLE ANTIBIOTICS. THE PATIENT WAS ALSO DIAGNOSED WITH DELIRIUM AND ENCEPHALOPATHY. FURTHER, SHE DEVELOPED ACUTE RENAL FAILURE, WHICH LATER RESOLVED. AT THE TIME OF DISCHARGE, SHE WAS ON PRESSURE SUPPORT, ON HEPARIN DRIP FOR LOWER EXTREMITY DEEP VEIN THROMBOSIS, ON MEDICATION FOR SEIZURES, AND WAS RECEIVING FEEDING THROUGH NASO-GASTRIAL TUBE. THE PATIENT WAS TRANSFERRED TO RESTORATIVE CARE UNIT ON (B)(6) 2010. THE DISCHARGE DIAGNOSIS INCLUDED LEFT HEMISPHERIC CEREBROVASCULAR INCIDENT. THE SITE REPORTED EVENT OF ISCHEMIC STROKE ON (B)(6)2012. (B)(4). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2010-00877 AND 1016427-2010-00141. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
THE (B)(6) FEMALE PATIENT WAS PART OF THE (B)(6) STUDY. THE PATIENT RECEIVED A PRECISE STENT IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY. DURING POST-DILATATION IN THE INDEX PROCEDURE, THE PATIENT HAD APHASIA WHICH WAS DIAGNOSED AN ISCHEMIC STROKE. EMERGENT CEA SURGERY WAS PERFORMED. PATIENT PARTIALLY RECOVERED AND HAD MAJOR RESIDUALS.
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 | 70710505 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | PRECISE STENT |