CYPHER SIROLIMUS-ELUTING CORONARY STENT
Report
- Report Number
- 3003742446-2013-00002
- Event Type
- Injury
- Date Received
- January 2, 2013
- Date of Event
- November 3, 2012
- Report Date
- October 7, 2013
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICATIONS INCLUDED AGGRENOX, ASPIRIN, ATENOLOL, B12, PLAVIX, BIVALIRUDIN, CARDURA, CELEXA, GLUCOPHAGE, GLUCOTROL, LASIX, PRILOSEC, PRINIVIL, ROPINIROLE, ZETIA, AND ZOCOR. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00002 AND 3003742446-2013-00003.
ADDENDUM: ADDITIONAL INFORMATION REGARDING (B)(6) 2012 PROCEDURE WAS RECEIVED. APPROXIMATELY 25 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT PERIPHERAL STENTING OF THE MID AND DISTAL SUPERFICIAL FEMORAL ARTERY DUE TO SEVERE 90% MID SFA LESION AND THEN A SHORT SEGMENT OF 100% OCCLUSION AT THE DISTAL SFA. NO NOTATION ON THE CORONARY ARTERIES SINCE THEY WERE WORKING ON FEMORAL ARTERIES. PREVIOUSLY REPORTED CODE FOR CORONARY ARTERY RESTENOSIS HAS BEEN REMOVED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00002 AND 3003742446-2013-00003.
ADDENDUM: ADDITIONAL INFORMATION RECEIVED THROUGH ADJUDICATION MINUTES. ON (B)(6) 2013 HE PRESENTED TO THE EMERGENCY DEPARTMENT FROM THE NURSING HOME WITH AGITATION AND SHORTNESS OF BREATH THAT HAD BEEN ONGOING FOR TWO DAYS. HE WAS INITIALLY FOUND TO BE HYPOXIC AND WAS PLACED ON NONREBREATHER MASK AND EVENTUALLY ON BIPAP. THE PATIENT HAD A DO NOT RESUSCITATE STATUS. THE FAMILY CAME AS THE PATIENT WAS STILL IN THE EMERGENCY DEPARTMENT WITH A DECISION TO REMOVE THE BIPAP AND TO PLACE THE PATIENT ON PALLIATIVE CARE. AT THE TIME OF ADMISSION, THE PATIENT WAS COMPLETELY UNRESPONSIVE. HE WAS DYSPNEIC AND DID NOT WAKE UP ON THE PHYSICAL EXAM. A CHEST X-RAY SHOWED SLIGHT INTERVAL INCREASE IN THE SIZE OF MODERATELY-SIZED BILATERAL PLEURAL EFFUSIONS WITH PATCHY BIBASILAR INFILTRATES. ON (B)(6) 2013 AT 17:30 THE CK WAS 66 (NL 204), CKMB WAS NOT TESTED, THE TROPONIN T WAS 0.047 (NL 0.009). PRO-BNP WAS 33,264, AND D-DIMER WAS 2.07. THE ECG CORE LAB REPORTED PERSISTENT RECENT/ACUTE ANTEROLATERAL/APICAL ST DEPRESSION AND NO NEW Q WAVES, BASED ON A TRACING ON (B)(6) 2013 AT 17:29. CONSULTATION ASSESSMENT: ACUTE ON CHRONIC RESPIRATORY FAILURE, ACUTE ON CHRONIC LEFT SYSTOLIC HEART FAILURE, HEALTHCARE ACQUIRED PNEUMONIA. THE PATIENT EXPIRED ON (B)(6) 2013 AT 10:50. THE DEATH CERTIFICATE REPORTED THE CAUSE OF DEATH AS RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE, AND HEALTHCARE ASSOCIATED PNEUMONIA. THE SITE REPORTED THE CAUSE OF DEATH AS CARDIAC. AS REPORTED BY CYPRESS STUDY THE PATIENT EXPERIENCED AN MI APPROXIMATELY THIRTY MONTHS POST INDEX PROCEDURE. PCI WAS PERFORMED ON A 99% DE NOVO LESION IN THE PROXIMAL LAD OF 15MM IN LENGTH IN A 2.25MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B2. IT WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT 8 ATM BEFORE A 2.5X18MM CYPHER STENT AT 16 ATM. POST-DILATION WAS NOT PERFORMED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOWS WERE RECORDED PRE AND POST PROCEDURE, RESPECTIVELY. PCI WAS PERFORMED NEXT ON A 95% DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX OF 18MM IN LENGTH IN A 4.0MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B2. IT WAS PRE-DILATED WITH A 3.5X15MM BALLOON AT 12 ATM BEFORE A 3.5X23MM CYPHER STENT AT 16 ATM. POST-DILATION WAS PERFORMED WITH A 4.0X20MM BALLOON CATHETER AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOWS WERE RECORDED PRE AND POST PROCEDURE, RESPECTIVELY. ADDITIONAL INFORMATION RECEIVED THROUGH ADJUDICATION MINUTES. ON 05/20/2013 HE PRESENTED TO THE EMERGENCY DEPARTMENT FROM THE NURSING HOME WITH AGITATION AND SHORTNESS OF BREATH THAT HAD BEEN ONGOING FOR TWO DAYS. HE WAS INITIALLY FOUND TO BE HYPOXIC AND WAS PLACED ON NONREBREATHER MASK AND EVENTUALLY ON BIPAP. THE PATIENT HAD A DO NOT RESUSCITATE STATUS. THE FAMILY CAME AS THE PATIENT WAS STILL IN THE EMERGENCY DEPARTMENT WITH A DECISION TO REMOVE THE BIPAP AND TO PLACE THE PATIENT ON PALLIATIVE CARE. AT THE TIME OF ADMISSION, THE PATIENT WAS COMPLETELY UNRESPONSIVE. HE WAS DYSPNEIC AND DID NOT WAKE UP ON THE PHYSICAL EXAM. A CHEST X-RAY SHOWED SLIGHT INTERVAL INCREASE IN THE SIZE OF MODERATELY-SIZED BILATERAL PLEURAL EFFUSIONS WITH PATCHY BIBASILAR INFILTRATES. ON (B)(6)2013 AT 17:30 THE CK WAS 66 (NL 204), CKMB WAS NOT TESTED, THE TROPONIN T WAS 0.047 (NL 0.009). PRO-BNP WAS 33,264, AND D-DIMER WAS 2.07. THE ECG CORE LAB REPORTED PERSISTENT RECENT/ACUTE ANTEROLATERAL/APICAL ST DEPRESSION AND NO NEW Q WAVES, BASED ON A TRACING ON (B)(6) 2013 AT 17:29. CONSULTATION ASSESSMENT: ACUTE ON CHRONIC RESPIRATORY FAILURE, ACUTE ON CHRONIC LEFT SYSTOLIC HEART FAILURE, HEALTHCARE ACQUIRED PNEUMONIA. THE PATIENT EXPIRED ON (B)(6) 2013 AT 10:50. THE DEATH CERTIFICATE REPORTED THE CAUSE OF DEATH AS RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE, AND HEALTHCARE ASSOCIATED PNEUMONIA. THE SITE REPORTED THE CAUSE OF DEATH AS CARDIAC. 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. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT¿S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00002 AND 3003742446-2013-00003.
ADDENDUM: ADDITIONAL INFORMATION RECEIVED THROUGH ADJUDICATION MINUTES REGARDING PREVIOUSLY DOCUMENTED ELEVATED CARDIAC ENZYMES ON (B)(6) 2012, (B)(6) 2013. IT WAS NOTED THAT THE COMMITTEE CONSIDERED THESE ELEVATED ENZYMES EVENTS DEEMED TO BE THE MYOCARDIAL INFARCTION. THE FILE HAS BEEN UPDATED WITH THE REPLACEMENT OF ELEVATED CARDIAC ENZYMES WITH MYOCARDIAL INFARCTION ((B)(6) 2012, (B)(6) 2013). SEE UPDATED CODES. FOLLOWING IS THE DETAILED SUMMARY AS INDICATED IN THE MINUTES. ON (B)(4) 2012 THE PATIENT PRESENTED WITH RIGHT ARM PAIN, SHORTNESS OF BREATH AND DYSPNEA ON EXERTION. PER DISCHARGE SUMMARY, THE PERTINENT STUDIES INCLUDED A FUNCTIONAL ISCHEMIA STUDY THAT REVEALED REVERSIBLE ISCHEMIA OF A SMALL PORTION OF THE INFEROLATERAL WALL OF THE LEFT VENTRICLE, NORMAL WALL MOTION, AND NORMAL EF. AS PER FIRST CARDIAC ENZYMES TESTING, CK WAS 26 (NL 204), THE CKMB WAS NOT TESTED, AND THE TROPONIN WAS 0.020 (NL 0.009). ANOTHER TEST REVEALED CK WAS 28, THE CKMB WAS NOT TESTED, AND THE TROPONIN WAS 0.020. AS PER THIRD WORKUP, CK WAS NOT TESTED, THE CKMB WAS 5.10 (NL 5.0), AND THE TROPONIN WAS NOT TESTED. AS PER FOURTH WORKUP, THE CK AND CKMB WERE NOT TESTED, AND THE TROPONIN WAS 0.020. PER DISCHARGE SUMMARY, THE RIGHT ARM PAIN WAS ¿LIKELY MUSCULOSKELETAL.¿ ON (B)(6) 2013, THE PATIENT PRESENTED TO THE HOSPITAL AFTER HE FELL IN HIS HOME. THE PATIENT DENIED CHEST PAIN OR SHORTNESS OF BREATH. INCREASING GENERALIZED WEAKNESS AND GAIT CHANGES WERE NOTED. HIS EF WAS NORMAL, ACCORDING TO THE SITE. AN X-RAY REVEALED A RIGHT INTRATROCHANTERIC HIP FRACTURE. HE HAD NO NEUROLOGICAL DEFICITS AND A BRAIN CT SCAN SHOWED NO ACUTE CHANGES. THE PATIENT WAS PLANNED TO UNDERGO A SURGICAL TREATMENT FOR THE FRACTURED HIP. AS PER FIRST SET OF CARDIAC ENZYMES, THE CK WAS NOT TESTED, THE CKMB WAS 6.80 (NL 5.0), AND THE TROPONIN WAS 0.014 (NL 0.009). AS PER SECOND SET, THE CK WAS NOT TESTED, THE CKMB WAS 6.50 (NL 5.0), AND THE TROPONIN WAS 0.014 (NL 0.009). AS PER THIRD SET, THE CK WAS NOT TESTED, THE CKMB WAS 5.40 AND THE TROPONIN WAS 0.015. AS PER FOURTH SET, THE CK WAS NOT TESTED, THE CKMB WAS 3.50, AND THE TROPONIN WAS 0.023. ON (B)(6) 2013 THE PATIENT PRESENTED WITH A HISTORY OF 2-3 WEEKS OF WORSENING SHORTNESS OF BREATH, EDEMA, PAROXYSMAL NOCTURNAL DYSPNEA, AND ORTHOPNEA. HE WAS ADMITTED FOR ACUTE-ON-CHRONIC LEFT-SIDED CONGESTIVE HEART FAILURE. ECHOCARDIOGRAPHY REVEALED SEVERE LV DYSFUNCTION, 25% BY ESTIMATION, WHICH REPORTED TO BE ¿A BIG CHANGE¿, COMPARED TO A STUDY PERFORMED A YEAR AGO, WHEN THE EF WAS 50-55%. THERE WAS SEVERE HYPOKINESIS OF INFEROLATERAL, LATERAL WALLS. MODERATE AORTIC STENOSIS WITH SEVERELY CALCIFIED AORTIC VALVE WAS NOTED. THE PATIENT WAS ALSO NOTED TO HAVE ¿SIGNIFICANTLY ELEVATED TROPONINS.¿ PER HOSPITAL LAB RECORD, THE CARDIAC ENZYME TEST RESULTS WERE AS FOLLOWS: 1ST SET: THE CK WAS 38 (NL 204), CKMB WAS NOT TESTED AND THE TROPONIN T WAS 0.043 (NL 0.009). 2ND SET: THE CK WAS NOT TESTED, THE CKMB WAS 4.60 AND 4.40 AND THE TROPONIN T WAS 0.043. 3RD SET: THE CK WAS NOT TESTED, THE CKMB WAS 4.40 AND THE TROPONIN T WAS 0.045. 4TH SET: THE CK WAS NOT TESTED, THE CKMB WAS 3.30 AND THE TROPONIN WAS 0.043. REPEAT ANGIOGRAPHY ON (B)(6) 2013 FOR HEART FAILURE, NON-ST ELEVATION MI AND CARDIOMYOPATHY REVEALED OCCLUDED LAD WITH PATENT LIMA GRAFT, MODERATE DIAGONAL BRANCH DISEASE, MILD DIFFUSE DOMINANT CX DISEASE WITH MODERATELY-SEVERE DISTAL CX DISEASE, OCCLUDED NON-DOMINANT RCA, BILATERAL AORTIC ILIAC DISEASE, LEFT GREATER THAN RIGHT, AND SMALL ABDOMINAL AORTIC ANEURYSM. RECOMMENDATIONS WERE FOR MEDICAL MANAGEMENT OF CARDIOMYOPATHY AND ISCHEMIC HEART DISEASE. ON (B)(6) 2013 HE PRESENTED TO THE EMERGENCY DEPARTMENT FROM THE NURSING HOME WITH AGITATION AND SHORTNESS OF BREATH THAT HAD BEEN ONGOING FOR TWO DAYS. HE WAS INITIALLY FOUND TO BE HYPOXIC AND WAS PLACED ON NONREBREATHER MASK AND EVENTUALLY ON BIPAP. THE PATIENT HAD A DO NOT RESUSCITATE STATUS. THE FAMILY CAME AS THE PATIENT WAS STILL IN THE EMERGENCY DEPARTMENT WITH A DECISION TO REMOVE THE BIPAP AND TO PLACE THE PATIENT ON PALLIATIVE CARE. AT THE TIME OF ADMISSION, THE PATIENT WAS COMPLETELY UNRESPONSIVE. HE WAS DYSPNEIC AND DID NOT WAKE UP ON THE PHYSICAL EXAM. A CHEST X-RAY SHOWED SLIGHT INTERVAL INCREASE IN THE SIZE OF MODERATELY-SIZED BILATERAL PLEURAL EFFUSIONS WITH PATCHY BIBASILAR INFILTRATES. AS REPORTED BY CYPRESS STUDY THE PATIENT EXPERIENCED MULTIPLE EVENTS OF MYOCARDIAL INFARCTION POST INDEX PROCEDURE. AT THE TIME OF INDEX, PCI WAS PERFORMED ON A 99% DE NOVO LESION IN THE PROXIMAL LAD OF 15MM IN LENGTH IN A 2.25MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B2. IT WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT 8 ATM BEFORE A 2.5X18MM CYPHER STENT AT 16 ATM. POST-DILATION WAS NOT PERFORMED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOWS WERE RECORDED PRE AND POST PROCEDURE, RESPECTIVELY. PCI WAS PERFORMED NEXT ON A 95% DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX OF 18MM IN LENGTH IN A 4.0MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B2. IT WAS PRE-DILATED WITH A 3.5X15MM BALLOON AT 12 ATM BEFORE A 3.5X23MM CYPHER STENT AT 16 ATM. POST-DILATION WAS PERFORMED WITH A 4.0X20MM BALLOON CATHETER AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOWS WERE RECORDED PRE AND POST PROCEDURE, RESPECTIVELY. ADDITIONAL INFORMATION RECEIVED THROUGH ADJUDICATION MINUTES. ON (B)(6) 2012 THE PATIENT PRESENTED WITH RIGHT ARM PAIN, SHORTNESS OF BREATH AND DYSPNEA ON EXERTION. PER DISCHARGE SUMMARY, THE PERTINENT STUDIES INCLUDED A FUNCTIONAL ISCHEMIA STUDY THAT REVEALED REVERSIBLE ISCHEMIA OF A SMALL PORTION OF THE INFEROLATERAL WALL OF THE LEFT VENTRICLE, NORMAL WALL MOTION, AND NORMAL EF. AS PER FIRST CARDIAC ENZYMES TESTING, CK WAS 26 (NL 204), THE CKMB WAS NOT TESTED, AND THE TROPONIN WAS 0.020 (NL 0.009). ANOTHER TEST REVEALED CK WAS 28, THE CKMB WAS NOT TESTED, AND THE TROPONIN WAS 0.020. AS PER THIRD WORKUP, CK WAS NOT TESTED, THE CKMB WAS 5.10 (NL 5.0), AND THE TROPONIN WAS NOT TESTED. AS PER FOURTH WORKUP, THE CK AND CKMB WERE NOT TESTED, AND THE TROPONIN WAS 0.020. PER DISCHARGE SUMMARY, THE RIGHT ARM PAIN WAS ¿LIKELY MUSCULOSKELETAL.¿ ON (B)(6) 2013, THE PATIENT PRESENTED TO THE HOSPITAL AFTER HE FELL IN HIS HOME. THE PATIENT DENIED CHEST PAIN OR SHORTNESS OF BREATH. INCREASING GENERALIZED WEAKNESS AND GAIT CHANGES WERE NOTED. HIS EF WAS NORMAL, ACCORDING TO THE SITE. AN X-RAY REVEALED A RIGHT INTRATROCHANTERIC HIP FRACTURE. HE HAD NO NEUROLOGICAL DEFICITS AND A BRAIN CT SCAN SHOWED NO ACUTE CHANGES. THE PATIENT WAS PLANNED TO UNDERGO A SURGICAL TREATMENT FOR THE FRACTURED HIP. AS PER FIRST SET OF CARDIAC ENZYMES, THE CK WAS NOT TESTED, THE CKMB WAS 6.80 (NL 5.0), AND THE TROPONIN WAS 0.014 (NL 0.009). AS PER SECOND SET, THE CK WAS NOT TESTED, THE CKMB WAS 6.50 (NL 5.0), AND THE TROPONIN WAS 0.014 (NL 0.009). AS PER THIRD SET, THE CK WAS NOT TESTED, THE CKMB WAS 5.40 AND THE TROPONIN WAS 0.015. AS PER FOURTH SET, THE CK WAS NOT TESTED, THE CKMB WAS 3.50, AND THE TROPONIN WAS 0.023. ON (B)(6) 2013 THE PATIENT PRESENTED WITH A HISTORY OF 2-3 WEEKS OF WORSENING SHORTNESS OF BREATH, EDEMA, PAROXYSMAL NOCTURNAL DYSPNEA, AND ORTHOPNEA. HE WAS ADMITTED FOR ACUTE-ON-CHRONIC LEFT-SIDED CONGESTIVE HEART FAILURE. ECHOCARDIOGRAPHY REVEALED SEVERE LV DYSFUNCTION, 25% BY ESTIMATION, WHICH REPORTED TO BE ¿A BIG CHANGE¿, COMPARED TO A STUDY PERFORMED A YEAR AGO, WHEN THE EF WAS 50-55%. THERE WAS SEVERE HYPOKINESIS OF INFEROLATERAL, LATERAL WALLS. MODERATE AORTIC STENOSIS WITH SEVERELY CALCIFIED AORTIC VALVE WAS NOTED. THE PATIENT WAS ALSO NOTED TO HAVE ¿SIGNIFICANTLY ELEVATED TROPONINS.¿ PER HOSPITAL LAB RECORD, THE CARDIAC ENZYME TEST RESULTS WERE AS FOLLOWS: 1ST SET: THE CK WAS 38 (NL 204), CKMB WAS NOT TESTED AND THE TROPONIN T WAS 0.043 (NL 0.009). 2ND SET: THE CK WAS NOT TESTED, THE CKMB WAS 4.60 AND 4.40 AND THE TROPONIN T WAS 0.043. 3RD SET: THE CK WAS NOT TESTED, THE CKMB WAS 4.40 AND THE TROPONIN T WAS 0.045. 4TH SET: THE CK WAS NOT TESTED, THE CKMB WAS 3.30 AND THE TROPONIN WAS 0.043. REPEAT ANGIOGRAPHY ON (B)(6) 2013 FOR HEART FAILURE, NON-ST ELEVATION MI AND CARDIOMYOPATHY REVEALED OCCLUDED LAD WITH PATENT LIMA GRAFT, MODERATE DIAGONAL BRANCH DISEASE, MILD DIFFUSE DOMINANT CX DISEASE WITH MODERATELY-SEVERE DISTAL CX DISEASE, OCCLUDED NON-DOMINANT RCA, BILATERAL AORTIC ILIAC DISEASE, LEFT GREATER THAN RIGHT, AND SMALL ABDOMINAL AORTIC ANEURYSM. RECOMMENDATIONS WERE FOR MEDICAL MANAGEMENT OF CARDIOMYOPATHY AND ISCHEMIC HEART DISEASE. ON (B)(6) 2013 HE PRESENTED TO THE EMERGENCY DEPARTMENT FROM THE NURSING HOME WITH AGITATION AND SHORTNESS OF BREATH THAT HAD BEEN ONGOING FOR TWO DAYS. HE WAS INITIALLY FOUND TO BE HYPOXIC AND WAS PLACED ON NONREBREATHER MASK AND EVENTUALLY ON BIPAP. THE PATIENT HAD A DO NOT RESUSCITATE STATUS. THE FAMILY CAME AS THE PATIENT WAS STILL IN THE EMERGENCY DEPARTMENT WITH A DECISION TO REMOVE THE BIPAP AND TO PLACE THE PATIENT ON PALLIATIVE CARE. AT THE TIME OF ADMISSION, THE PATIENT WAS COMPLETELY UNRESPONSIVE. HE WAS DYSPNEIC AND DID NOT WAKE UP ON THE PHYSICAL EXAM. A CHEST X-RAY SHOWED SLIGHT INTERVAL INCREASE IN THE SIZE OF MODERATELY-SIZED BILATERAL PLEURAL EFFUSIONS WITH PATCHY BIBASILAR INFILTRATES. ON (B)(6) 2013 AT 17:30 THE CK WAS 66 (NL 204), CKMB WAS NOT TESTED, THE TROPONIN T WAS 0.047 (NL 0.009). PRO-BNP WAS 33,264, AND D-DIMER WAS 2.07. THE ECG CORE LAB REPORTED PERSISTENT RECENT/ACUTE ANTEROLATERAL/APICAL ST DEPRESSION AND NO NEW Q WAVES, BASED ON A TRACING ON (B)(6) 2013 AT 17:29. CONSULTATION ASSESSMENT: ACUTE ON CHRONIC RESPIRATORY FAILURE, ACUTE ON CHRONIC LEFT SYSTOLIC HEART FAILURE, HEALTHCARE ACQUIRED PNEUMONIA. THE PATIENT EXPIRED ON (B)(6) 2013 AT 10:50. THE DEATH CERTIFICATE REPORTED THE CAUSE OF DEATH AS RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE, AND HEALTHCARE ASSOCIATED PNEUMONIA. THE SITE REPORTED THE CAUSE OF DEATH AS CARDIAC. 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. MYOCARDIAL INFARCTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT¿S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THESE ADVERSE EVENTS IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00002 AND 3003742446-2013-00003.
AS REPORTED BY (B)(6), THE PATIENT EXPERIENCED AN MAE - REVASCULARIZATION APPROXIMATELY (B)(6) POST INDEX PROCEDURE. PCI WAS PERFORMED ON A 99% DE NOVO LESION IN THE PROXIMAL LAD OF 15 MM IN LENGTH IN A 2.25 MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B2. IT WAS PRE-DILATED WITH A 2.5 X 15 MM BALLOON AT 8 ATM BEFORE A 2.5 X 18 MM CYPHER STENT AT 16 ATM. POST-DILATION WAS NOT PERFORMED. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOWS WERE RECORDED PRE AND POST PROCEDURE, RESPECTIVELY. PCI WAS PERFORMED NEXT ON A 95% DE NOVO LESION IN THE PROXIMAL CIRCUMFLEX OF 18 MM IN LENGTH IN A 4.0 MM VESSEL DIAMETER. THE LESION WAS CLASSIFIED AS B2. IT WAS PRE-DILATED WITH A 3.5 X 15 MM BALLOON AT 12 ATM BEFORE A 3.5 X 23 MM CYPHER STENT AT 16 ATM. POST-DILATION WAS PERFORMED WITH A 4.0 X 20 MM BALLOON CATHETER AT 18 ATM. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. TIMI III FLOWS WERE RECORDED PRE AND POST PROCEDURE, RESPECTIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 924 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | 15226607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| L| R |