PRECISE PRO RX CAROTID STENT SYSTEM

Report

Report Number: 9616099-2011-00035
Event Type: Death
Date Received: January 13, 2011
Date of Event: December 2, 2010
Report Date: December 17, 2010
Manufacturer: CORDIS DE MEXICO
Product Code: NIM
PMA / PMN Number: P030047
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION RECEIVED INDICATES THAT THE DEATH WAS DUE TO CONGESTIVE HEART FAILURE. THEREFORE, THERE IS NO INDICATION THAT THE DEATH IS RELATED TO THE CORDIS PRODUCTS WHICH WERE IMPLANTED IN THE PATIENT'S CAROTID ARTERY. THE EVENT IS NO LONGER CONSIDERED A REPORTABLE EVENT PER FDA GUIDELINES.

Additional Manufacturer Narrative · 1

THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00035 AND 9616099-2011-00036. OPERATIVE REPORT WAS RECEIVED THAT STATED DURING THE INDEX PROCEDURE, THE PHYSICIAN PREPPED AND SHAPED THE 6MM ANGIOGUARD; HOWEVER, HE WAS UNABLE TO GET THE ANGIOGUARD AROUND THE FIRST C-LOOP IN THE INTERNAL CAROTID ARTERY. A SECOND 6MM ANGIOGUARD WAS ALSO UNSUCCESSFUL. AN EV3 SPIDER FILTER WAS USED AND AN UNKNOWN BALLOON CATHETER WAS USED TO PRE-DILATE THE LESION AND A 7X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. AN 8X30MM PRECISE PRO STENT WAS SUCCESSFULLY IMPLANTED OVERLAPPING THE FIRST STENT. NO POST-DILATION WAS PERFORMED. ANGIOGRAMS REVEALED GOOD POSITIONING OF THE STENTS WITH NO RESIDUAL DISEASE OR SPASM. THERE WAS NO EVIDENCE OF DISTAL EMOBILIZATION. THE PATIENT WAS TRANSPORTED TO RECOVERY HEMODYNAMICALLY STABLE AND NEUROLOGICALLY INTACT. THERE WERE NO COMPLICATIONS.

Additional Manufacturer Narrative · 1

THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2011-00035 AND 9616099-2011-00036. AS REPORTED BY THE SAPPHIRE STUDY, THE PATIENT EXPIRED APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE. THE PATIENT'S HISTORY INCLUDES STROKE, HYPERLIPIDEMIA, AND HYPERTENSION. THE TARGET LESION WAS LOCATED IN THE MID LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 80% STENOSED, 35MM IN LENGTH, NON-THROMBOSED, ARCH TYPE II, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 5.0MM IN DIAMETER AND SEVERELY TORTUOUS. THE LESION WAS PRE-DILATED AND A 6MM ANGIOGUARD RX WAS UNABLE TO BE DEPLOYED AND WAS RETRIEVED. A SECOND 6MM ANGIOGUARD RX WAS ALSO NOT ABLE TO BE DEPLOYED AND WAS SUBSEQUENTLY RETRIEVED. THERE WAS NO DEBRIS NOTED IN THE ANGIOGUARD RX BASKETS AND THERE WERE NO REPORTED TECHNICAL PROBLEMS. AN EV3 SPIDER NON STUDY EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED BEYOND THE TARGET LESION AND A 7X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. AN ADDITIONAL 8X30MM PRECISE PRO RX STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT. THERE WERE NO AIR BUBBLES PRESENT. THE EV3 SPIDER WAS RETRIEVED AND THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. MEDICAL RECORDS INDICATE THE PATIENT HAS A HISTORY OF END-STAGE PULMONARY HYPERTENSION AND CHRONIC DIASTOLIC HEART FAILURE WHO PRESENTED TO THE EMERGENCY ROOM WITH INCREASING SHORTNESS OF BREATH. SHE WAS FOUND WITH EVIDENCE OF ACUTE CHRONIC SYSTOLIC HEART FAILURE AND SEVERE PULMONARY HYPERTENSION. UPON ADMISSION TO THE HOSPITAL, SHE WAS FOUND THAT SHE HAD NO REVERSIBLE DISEASE, AND A DECISION WAS MADE FOR HER TO BE TRANSFERRED TO A FACILITY FOR COMFORT MEASURES ONLY. SHE BECAME CLINICALLY MORE UNSTABLE AND WAS SEEN BY A CONSULTANT FOR COMFORT MEASURES ONLY. TWO WEEKS AFTER ADMISSION, THE PATIENT EXPIRED. (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 15029782 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. (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 14132974 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ALTHOUGH THE CAUSE OF DEATH WAS NOT PROVIDED, BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE ETIOLOGY FOR THE PATIENT'S DEATH WAS LIKELY DUE TO END-STAGE PULMONARY HYPERTENSION AND CHRONIC DIASTOLIC HEART FAILURE AND WAS NOT NEUROLOGIC IN NATURE. 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.

Description of Event or Problem · 1

AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPIRED APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE MID LEFT INTERNAL CAROTID ARTERY (ICA). THE LESION WAS DESCRIBED AS 80% STENOSED, 35MM IN LENGTH, NON-THROMBOSED, ARCH TYPE II, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 5.0MM IN DIAMETER AND SEVERELY TORTUOUS. THE LESION WAS PRE-DILATED AND A 6MM ANGIOGUARD RX WAS NOT DEPLOYED AND WAS RETRIEVED. A SECOND 6MM ANGIOGUARD RX WAS NOT DEPLOYED AND WAS SUBSEQUENTLY RETRIEVED. THERE WAS NO DEBRIS NOTED IN THE ANGIOGUARD RX BASKETS AND THERE WERE NO REPORTED TECHNICAL PROBLEMS. AN EV3 SPIDER NON STUDY EMBOLIC PROTECTION DEVICE WAS DEPLOYED BEYOND THE TARGET LESION AND A 7X40MM PRECISE PRO RX STENT WAS SUCCESSFULLY IMPLANTED. AN 8X30MM PRECISE PRO RX STENT WAS IMPLANTED OVERLAPPING THE FIRST STENT. THERE WERE NO AIR BUBBLES PRESENT. THE EV3 SPIDER WAS RETRIEVED AND THE PATIENT LEFT THE ANGIOGRAPHY SUITE WITH NO NEUROLOGICAL DEFICIT. APPROXIMATELY ELEVEN MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. MEDICAL RECORDS INDICATE THE PATIENT HAS A HISTORY OF END-STAGE PULMONARY HYPERTENSION, CHRONIC DIASTOLIC HEART FAILURE WHO PRESENTED TO THE EMERGENCY ROOM WITH INCREASING SHORTNESS OF BREATH. SHE WAS FOUND WITH EVIDENCE OF ACUTE CHRONIC SYSTOLIC HEART FAILURE AND SEVERE PULMONARY HYPERTENSION. UPON ADMISSION TO THE HOSPITAL, SHE WAS FOUND THAT SHE HAD NO REVERSIBLE DISEASE, AND A DECISION WAS MADE FOR HER TO BE TRANSFERRED TO A FACILITY FOR COMFORT MEASURES ONLY. SHE BECAME CLINICALLY MORE UNSTABLE AND WAS SEEN BY A CONSULTANT FOR COMFORT MEASURES ONLY. TWO WEEKS AFTER ADMISSION, THE PATIENT EXPIRED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED (B)(6) 2011: THE CAUSE OF DEATH FROM THE DEATH CERTIFICATE WAS CONGESTIVE HEART FAILURE.

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	14132974

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Death	EV3 NON STUDY EMBOLIC PROTECTION DEVICE.