PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2010-00688
- Event Type
- Injury
- Date Received
- September 14, 2010
- Date of Event
- July 28, 2010
- Report Date
- August 18, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- OTHER
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION RECEIVED THAT AFTER THE INDEX THE PATIENT HAD STENT THROMBOSIS PER PROGRESS NOTES IN CHART. ONSET OCCURRED ACUTELY IN RECOVERY ROOM....PATIENT WAS EMERGENTLY RETURNED TO OPERATING ROOM FOR STENT THROMBECTOMY. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
ADDITIONAL INFORMATION RECEIVED THAT AFTER THE INDEX THE PATIENT HAD STENT THROMBOSIS PER PROGRESS NOTES IN CHART. ONSET OCCURRED ACUTELY IN THE RECOVERY ROOM AND THE PATIENT WAS EMERGENTLY RETURNED TO OPERATING ROOM FOR STENT THROMBECTOMY. AS REPORTED BY THE (B)(4) REGISTRY, THE SAME DAY AFTER THE PATIENT HAD A PRECISE STENT IMPLANTED IN THE LEFT PROXIMAL OF CAROTID ARTERY THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. THE PATIENT MEDICAL HISTORY INCLUDES STROKES, HYPERLIPIDEMIA, FIRST-DEGREE RELATIVE WITH PREMATURE CAD (FEMALE (B)(6) OR MALE (B)(6).), CLINICAL COPD, SMOKING AND HYPERTENSION. THE PATIENT HAS HIGH RISK CRITERIA OF SEVERE PULMONARY DISEASE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS OF THE LEFT PROXIMAL OF CAROTID ARTERY. THE LESION WAS DESCRIBED AS 30MM IN LENGTH, MODERATE CONCENTRIC AND CIRCUMFERENTIAL CALCIFICATION AND ECCENTRIC. THE REFERENCE VESSEL WAS 8MM IN DIAMETER. THE PATIENT'S PRE-PROCEDURE NIH STROKE SCALE SCORE WAS 3. THE PATIENT WAS SYMPTOMATIC. AN ANGIOGUARD RX WITH A 4MM BASKET WAS DEPLOYED BEYOND THE LESION. AN 8 X 40MM PRECISE PRO RX STENT WAS IMPLANTED AFTER PRE-DILATION, WITH 5% RESIDUAL STENOSIS. POST DEPLOYMENT THROMBUS WAS NOTED. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL DEFICIT. PRESENCE OF AIR BUBBLES WAS NOT NOTED. APPROXIMATELY 30-45 MINUTES POST INDEX PROCEDURE THE PATIENT EXPERIENCED BEHAVIORAL CHANGES, APHASIA, REFLEX CHANGE, HEMIPARESIS AND HEMINEGLECT. THE ONSET WAS SUDDEN. THE PATIENT WAS DIAGNOSED WITH A LEFT HEMISPHERIC ISCHEMIC STROKE. THE PATIENT HAS PARTIAL RECOVERY OF MOTOR FUNCTION IN THE RIGHT LOWER EXTREMITY, AND PARALYSIS OF RIGHT OF RIGHT UPPER EXTREMITY. THE PATIENT WAS DISCHARGED APPROXIMATELY SEVEN DAYS AFTER THE INDEX PROCEDURE AND IS CURRENTLY UNDERGOING PHYSICAL REHABILITATION. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS STENT. 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 15108345 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE PRODUCT WAS 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. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY. THE ACT OF POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). STROKE IS ASSOCIATED WITH A STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. 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. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF STENT IMPLANTATION PRODUCES INTENDED DAMAGE TO THE INTIMA OF THE VESSEL WALL IN ORDER TO REMODEL THE WALL AND REESTABLISH PATENCY OF THE VESSEL. THE DISRUPTION OF THE INTIMAL LAYERS TRIGGERS THE IMMUNE SYSTEM TO HEAL THE DAMAGED AREAS, THUS ACTIVATING THE CLOTTING MECHANISM AS WELL AS THE INFLAMMATORY RESPONSE. SEVERAL FACTORS, INCLUDING MECHANICAL PLAQUE DISRUPTION, INTIMAL INJURY, AND STENT THROMBOGENICITY PREDISPOSE THE PATIENT TO THROMBOEMBOLIC EVENTS. PLATELET ADHESION, ACTIVATION, AND AGGREGATION PLAY MAIN ROLES IN MURAL THROMBUS FORMATION. THE COMBINATION OF INFLAMMATORY RESPONSE AND CLOTTING CASCADE CAN LEAD TO THROMBUS FORMATION IN SIDE OF THE STENT AROUND THE DAMAGED AREAS. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.
DURING THE PROCEDURE, A 7FR SHEATH INTRODUCER WAS USED. AS REPORTED BY THE (B)(4) REGISTRY, THE SAME DAY AFTER THE PATIENT HAD A PRECISE STENT IMPLANTED IN THE LEFT PROXIMAL OF CAROTID ARTERY THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. THE PATIENT MEDICAL HISTORY INCLUDES STROKES, HYPERLIPIDEMIA, FIRST-DEGREE RELATIVE WITH PREMATURE CAD (FEMALE <65 Y.O. OR MALE <55 Y.O.), CLINICAL COPD, SMOKING AND HYPERTENSION. THE PATIENT HAS HIGH RISK CRITERIA OF SEVERE PULMONARY DISEASE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS OF THE LEFT PROXIMAL OF CAROTID ARTERY. THE LESION WAS DESCRIBED AS 30MM IN LENGTH, MODERATE CONCENTRIC AND CIRCUMFERENTIAL CALCIFICATION AND ECCENTRIC. THE REFERENCE VESSEL WAS 8MM IN DIAMETER. THE PATIENT'S PRE-PROCEDURE (B)(6) STROKE SCALE SCORE WAS 3. THE PATIENT WAS SYMPTOMATIC. AN ANGIOGUARD RX WITH A 4MM BASKET WAS DEPLOYED BEYOND THE LESION. AN 8 X 40MM PRECISE PRO RX STENT WAS IMPLANTED AFTER PRE-DILATION, WITH 5% RESIDUAL STENOSIS. POST DEPLOYMENT THROMBUS WAS NOTED. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL DEFICIT. PRESENCE OF AIR BUBBLES WAS NOT NOTED. APPROXIMATELY 30-45 MINUTES POST INDEX PROCEDURE, THE PATIENT EXPERIENCED BEHAVIORAL CHANGES, APHASIA, REFLEX CHANGE, HEMIPARESIS AND HEMINEGLECT. THE ONSET WAS SUDDEN. THE PATIENT WAS DIAGNOSED WITH A LEFT HEMISPHERIC ISCHEMIC STROKE. THE PATIENT HAS PARTIAL RECOVERY OF MOTOR FUNCTION IN THE RIGHT LOWER EXTREMITY, AND PARALYSIS OF RIGHT OF RIGHT UPPER EXTREMITY. THE PATIENT WAS DISCHARGED APPROXIMATELY SEVEN DAYS AFTER THE INDEX PROCEDURE AND IS CURRENTLY UNDERGOING PHYSICAL REHABILITATION. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS STENT. 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 15108345 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. 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. ISCHEMIC STROKE IS A KNOWN POTENTIAL RISK ASSOCIATED WITH IMPLANTING A STENT IN A CAROTID ARTERY. THE ACT OF POST-DILATATION, TO OPTIMALLY OPPOSE A CAROTID STENT TO THE VESSEL WALL, TEMPORARILY OBSTRUCTS BLOOD FLOW TO THE CEREBRAL ARTERIES (ISCHEMIC PROCESS). STROKE IS ASSOCIATED WITH A STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. 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. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE.
AS REPORTED BY THE (B)(4) REGISTRY, THE SAME DAY AFTER THE PATIENT HAD A PRECISE STENT IMPLANTED IN THE LEFT PROXIMAL OF CAROTID ARTERY THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 95% STENOSIS OF THE LEFT PROXIMAL OF CAROTID ARTERY. THE LESION WAS DESCRIBED AS 30MM IN LENGTH, MODERATE CONCENTRIC AND CIRCUMFERENTIAL CALCIFICATION AND ECCENTRIC. THE REFERENCE VESSEL WAS 8MM IN DIAMETER. THE PATIENT'S PRE-PROCEDURE (B)(6) STROKE SCALE SCORE WAS 3. THE PATIENT WAS SYMPTOMATIC. AN ANGIOGUARD RX WITH A 4MM BASKET WAS DEPLOYED BEYOND THE LESION. AN 8 X 40MM PRECISE PRO RX STENT WAS IMPLANTED AFTER PRE-DILATION, WITH 5% RESIDUAL STENOSIS. POST DEPLOYMENT THROMBUS WAS NOTED. THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITHOUT NEUROLOGICAL DEFICIT. PRESENCE OF AIR BUBBLES WAS NOT NOTED. APPROXIMATELY 30-45 MINUTES POST INDEX PROCEDURE, THE PATIENT EXPERIENCED BEHAVIORAL CHANGES, APHASIA AND REFLEX CHANGE. THE PATIENT ALSO EXPERIENCED HEMIPARESIS AND HEMINEGLECT. THE ONSET WAS SUDDEN. THE PATIENT RESPONDED TO TREATMENT AND THE EVENT LASTED LESS THAN 24 HOURS. THE PATIENT WAS DIAGNOSED WITH A STROKE (ISCHEMIC) IN THE LEFT HEMISPHERE. THE PATIENT PARTIALLY RECOVERED WITH MAJOR RESIDUAL. THE PATIENT HAS PARTIAL RECOVERY OF MOTOR FUNCTION IN THE RIGHT LOWER EXTREMITY, AND PARALYSIS OF RIGHT OF RIGHT UPPER EXTREMITY. THE PATIENT WAS DISCHARGED APPROXIMATELY SEVEN DAYS AFTER THE INDEX PROCEDURE. PATIENT IS CURRENTLY UNDERGOING PHYSICAL REHABILITATION. THE EVENT WAS REPORTED TO BE UNRELATED TO THE CORDIS STENT. THE PATIENT HAS PARTIAL RECOVERY OF MOTOR FUNCTION, WITH MAJOR RESIDUAL. THE PATIENT DOES NOT HAVE ANY ALLERGIES TO NITINOL, NICKEL OR TITANIUM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15108345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Life Threatening| H| R | (SEE H10) |