PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2010-00394
- Event Type
- Death
- Date Received
- May 21, 2010
- Date of Event
- November 30, 2009
- Report Date
- May 20, 2010
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
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.
INFORMATION WAS RECEIVED VIA THAT (B) (4) STUDY THAT THIS PATIENT RECEIVED A PRECISE STENT IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY(IC) AND WAS DISCHARGED THE NEXT DAY. IT WAS INITIALLY REPORTED THAT A WEEK LATER, THE PATIENT SUFFERED AN MI AND SUBSEQUENTLY PASSED AWAY. IT WAS INDICATED THAT THE EVENT WAS UNRELATED TO BOTH THE INDEX PROCEDURE AND THE IMPLANTED STENT. ADJUDICATION MINUTES HAVE BEEN RECEIVED AND REVIEWED. THE ADJUDICATION MINUTES DISAGREE WITH THE PREVIOUSLY REPORTED CAUSE OF THE PATIENT¿S DEATH LISTED AS A MYOCARDIAL INFARCTION (MI). THE ADJUDICATION COMMITTEE (CEC) FOUND NO EVIDENCE OF AN MI. IN ABSENCE OF COMPLETE DATA AND BASED ON BEST CLINICAL JUDGMENT AND THE PROTOCOL DEFINITION OF DEATH, THE CEC HAS DETERMINED THAT THE CAUSE OF THE DEATH WAS NEUROLOGICAL AND THAT THE DEATH WAS RELATED TO THE INDEX PROCEDURE. AT BASELINE, IT WAS INDICATED THAT THE (B) (6) FEMALE HAD SYNCHRONOUS SEVERE CARDIAC AND BILATERAL CAROTID DISEASE REQUIRING OPEN-HEART SURGERY AND CAROTID REVASCULARIZATION. ADDITIONAL HISTORY INCLUDED AND CONGESTIVE HEART FAILURE, HISTORY OF SMOKING, DIABETES MELLITUS, CORONARY ARTERY DISEASE, RECENT MYOCARDIAL INFARCTION (GREATER THAN 24HRS. AND LESS THAN 6 WEEKS)\ , CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. (B) (6). AT BASE LINE THE (B) (6) STROKE SCORE AND (B) (6) STROKE SCORE WERE DOCUMENTED AS 0. IT WAS INDICATED THAT THERE WAS A 90% STENOSIS OF THE RIGHT ICA OSTIUM WITH A LESION LENGTH OF 21MM. THERE WAS MODERATE VESSEL TORTUOSITY. THE ULCERATED LESION HAD MILD CALCIFICATION WITH NO TARGET LESION THROMBUS. THE REFERENCE DIAMETER WAS 5.0MM. A 7MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED WITHOUT TECHNICAL PROBLEMS OR ASSOCIATED MAJOR ADVERSE EVENTS. THE LESION WAS PREDILATED WITH NO DOCUMENTED RESISTANCE OR DISSECTION. THE 10X40 PRECISE PRO RX WAS DEPLOYED AT THE TARGET LESION WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. THE TOTAL LENGTH OF THE STENTED SEGMENT WAS 40MM WITH A FINAL TARGET LESION DIAMETER STENOSIS OF 0%. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED WITHOUT TECHNICAL PROBLEMS OR ASSOCIATED MAJOR ADVERSE EVENTS WITH NO DEBRIS. THERE WAS NO ELEVATION OF CK OR CKMB VALUES ONE DAY POST PROCEDURE AND POST PROCEDURE (B) (6) AND (B) (6) STROKE SCORE SCALES WERE UNCHANGED FROM BASELINE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. DUE TO THE LACK OF INFORMATION REGARDING THE REPORTED PATIENT DEATH ONE WEEK POST RIGHT CAROTID ARTERY STENTING WITH A PRECISE STENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THE PATIENT¿S SIGNIFICANT MEDICAL HISTORY PUT HER AT AN INCREASED RISK FOR ADVERSE EVENTS INCLUDING DEATH. 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 15000551 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
INFORMATION WAS RECEIVED VIA THAT (B) (4) STUDY THAT THIS PATIENT RECEIVED A PRECISE STENT IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY(IC) AND WAS DISCHARGED THE NEXT DAY. IT WAS INITIALLY REPORTED THAT A WEEK LATER, THE PATIENT SUFFERED AN MI AND SUBSEQUENTLY PASSED AWAY. IT WAS INDICATED THAT THE EVENT WAS UNRELATED TO BOTH THE INDEX PROCEDURE AND THE IMPLANTED STENT. ADJUDICATION MINUTES HAVE BEEN RECEIVED AND REVIEWED. THE ADJUDICATION MINUTES DISAGREE WITH THE PREVIOUSLY REPORTED CAUSE OF THE PATIENT¿S DEATH LISTED AS A MYOCARDIAL INFARCTION (MI). THE ADJUDICATION COMMITTEE (CEC) FOUND NO EVIDENCE OF AN MI. IN ABSENCE OF COMPLETE DATA AND BASED ON BEST CLINICAL JUDGMENT AND THE PROTOCOL DEFINITION OF DEATH, THE CEC HAS DETERMINED THAT THE CAUSE OF THE DEATH WAS NEUROLOGICAL AND THAT THE DEATH WAS RELATED TO THE INDEX PROCEDURE. AT BASELINE, IT WAS INDICATED THAT THE (B) (6) FEMALE HAD SYNCHRONOUS SEVERE CARDIAC AND BILATERAL CAROTID DISEASE REQUIRING OPEN-HEART SURGERY AND CAROTID REVASCULARIZATION. ADDITIONAL HISTORY INCLUDED AND CONGESTIVE HEART FAILURE, HISTORY OF SMOKING, DIABETES MELLITUS, CORONARY ARTERY DISEASE, RECENT MYOCARDIAL INFARCTION (GREATER THAN 24HRS. AND LESS THAN 6WEEKS), CORONARY PERCUTANEOUS REVASCULARIZATION, AND HYPERTENSION. (B) (6). AT BASE LINE THE (B) (6) STROKE SCORE AND (B) (6) STROKE SCORE WERE DOCUMENTED AS 0. IT WAS INDICATED THAT THERE WAS A 90% STENOSIS OF THE RIGHT ICA OSTIUM WITH A LESION LENGTH OF 21MM. THERE WAS MODERATE VESSEL TORTUOSITY. THE ULCERATED LESION HAD MILD CALCIFICATION WITH NO TARGET LESION THROMBUS. THE REFERENCE DIAMETER WAS 5.0MM. A 7MM ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED WITHOUT TECHNICAL PROBLEMS OR ASSOCIATED MAJOR ADVERSE EVENTS. THE LESION WAS PREDILATED WITH NO DOCUMENTED RESISTANCE OR DISSECTION. THE 10X40 PRECISE PRO RX WAS DEPLOYED AT THE TARGET LESION WITH NO MALFUNCTION OR ASSOCIATED MAJOR ADVERSE EVENT. THE TOTAL LENGTH OF THE STENTED SEGMENT WAS 40MM WITH A FINAL TARGET LESION DIAMETER STENOSIS OF 0%. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED WITHOUT TECHNICAL PROBLEMS OR ASSOCIATED MAJOR ADVERSE EVENTS WITH NO DEBRIS. THERE WAS NO ELEVATION OF CK OR CKMB VALUES ONE DAY POST PROCEDURE AND POST PROCEDURE (B) (6) AND (B) (6) STROKE SCORE SCALES WERE UNCHANGED FROM BASELINE. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. DUE TO THE LACK OF INFORMATION REGARDING THE REPORTED PATIENT DEATH ONE WEEK POST RIGHT CAROTID ARTERY STENTING WITH A PRECISE STENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THE PATIENT¿S SIGNIFICANT MEDICAL HISTORY PUT HER AT AN INCREASED RISK FOR ADVERSE EVENTS INCLUDING DEATH. 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 15000551 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.
THE CUSTOMER STATES THAT ONE SET OF PATIENT RESULTS GENERATED ON THE CELL-DYN 4000 ANALYZER WERE QUESTIONED BY A PHYSICIAN AS BEING LOWER THAN EXPECTED. THE SAMPLE WAS THEN RETESTED ON ANOTHER SYSTEM WITH HIGHER RESULTS: INITIAL: WBC: 8.69, RBC(I): 3.00, HGB: 4.49 , MCV: 86.5 , PLT(O): 108; RETEST WBC: 10.8 RBC(I): 5.21 HGB: 10.0 MCV: 85.7 PLT(O): 199; [5.34 RBC(O)] , [189 PLT(I)]. THE PATIENT WAS SENT TO THE EMERGENCY ROOM (NO FURTHER INFORMATION AVAILABLE). CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. A PRECISION RUN PERFORMED IMMEDIATELY AFTER THESE RESULTS WERE GENERATED MET ALL SPECIFICATIONS IN BOTH OPEN AND CLOSED MODES OF OPERATION. THERE IS NO FURTHER IMPACT TO PATIENT MANAGEMENT REPORTED. UNITS OF MEASURE: WBC IN K/UL; RBC IN M/UL; HGB (HEMOGLOBIN) IN MMOL/L; MCV IN FL; PLT (PLATELETS) IN K/UL. (I) = IMPEDENCE COUNTS. (O)= OPTICAL COUNTS.
THE (B) (6) FEMALE PATIENT RECEIVED A PRECISE STENT IN THE OSTIUM OF THE INTERNAL CAROTID ARTERY. PATIENT WAS DISCHARGED ONE DAY AFTER THE PROCEDURE. A WEEK LATER, THE PATIENT SUFFERED AN MI AND SUBSEQUENTLY PASSED AWAY. THE EVENT WAS GRADED AS UNRELATED TO BOTH THE INDEX PROCEDURE AND THE IMPLANTED STENT. THE ADJUDICATION MINUTES OF 5/4/10 DISAGREE WITH THE PREVIOUSLY REPORTED CAUSE OF THE PATIENT¿S DEATH LISTED AS A MYOCARDIAL INFARCTION (MI). THIS EVENT WAS ORIGINALLY CODED AS A NON-COMPLAINT AS THE DEATH CERTIFICATE LISTS THE CAUSE OF DEATH AS AN MI AND THE EVENT WAS NOTED TO BE UNRELATED TO BOTH THE INDEX PROCEDURE AND THE PRECISE STENT. THE ADJUDICATION COMMITTEE (CEC) FOUND NO EVIDENCE OF AN MI. IN ABSENCE OF COMPLETE DATA AND BASED ON BEST CLINICAL JUDGMENT AND THE PROTOCOL DEFINITION OF DEATH, THE CEC HAS DETERMINED THAT THE CAUSE OF THE DEATH WAS NEUROLOGICAL AND THAT THE DEATH WAS RELATED TO THE INDEX PROCEDURE.
IT HAS BEEN REPORTED THAT THE LIFT ON THE BED WAS NOT OPERATING PROPERLY. NO INJURY WAS REPORTED.
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 | 15000551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death | ANGIOGUARD DEVICE |