PRECISE PRO RX CAROTID STENT SYSTEM
Report
- Report Number
- 9616099-2013-00321
- Event Type
- Injury
- Date Received
- May 24, 2013
- Date of Event
- May 2, 2013
- Report Date
- May 3, 2013
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIM
- PMA / PMN Number
- P030047
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
ADDITIONAL INFORMATION AND HAS BEEN RECEIVED AND NOTED THE FOLLOWING: THE PATIENT IS A PLEASANT (B)(6) GENTLEMAN WHO SUFFERED A RIGHT HEMISPHERIC STROKE EARLY IN MARCH. HIS HOSPITAL COURSE AT THAT TIME WAS COMPLICATED BY ASPIRATION PNEUMONIA. HE SPENT APPROXIMATELY 6 WEEKS IN REHABILITATION. HE WAS NOTED TO HAVE HIGH-GRADE STENOSIS OF HIS RIGHT CAROTID ARTERY. MOST OF HIS NEUROLOGIC FUNCTION HAD RETURNED TO BASELINE. HE WAS ADMITTED FOR AN ELECTIVE CAROTID STENT PER THE SAPPHIRE STUDY PROTOCOL. HE UNDERWENT STENTING TO HIS RIGHT INTERNAL CAROTID ARTERY. APPROXIMATELY AN HOUR OR SO POST-PROCEDURE HE DEVELOPED A LEFT HEMIPARESIS WITH APHASIA. A STAT HEAD CT SCAN WAS PERFORMED WHICH DEMONSTRATED HIGH ATTENUATION IN THE GYRI OF THE RIGHT FRONTAL LOBE SUGGESTING CORTICAL HEMORRHAGE PROBABLY FROM REPERFUSION. THERE WAS ALSO SOME LOW ATTENUATION IN THE RIGHT POSTERIOR FRONTAL LOBE WHICH MAY OR MAY NOT HAVE BEEN RELATED TO HIS PREVIOUS STROKE IN MARCH. HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. HIS NEUROLOGIC FUNCTION DID IMPROVE. THE PATIENT HAS SINCE BEEN ADMITTED TO HOSPICE CARE. HEAD CT WITHOUT CONTRAST SHOWS CEREBRAL ATROPHY WITH A NEW AREA OF LOW ATTENUATION IN THE POSTERIOR RIGHT FRONTAL LOBE. THE GYRI ARE HIGH ATTENUATION IN THIS REGION SUGGESTING PETECHIAL HEMORRHAGE WITHIN THE GYRI OR LESS LIKELY SUBARACHNOID HEMORRHAGE. THERE IS NO INTRAPARENCHYMAL HEMORRHAGE. NO SIGNIFICANT MASS EFFECT OR MIDLINE SHIFT. BONY CALVARIUM IS INTACT. THERE IS MUCOSAL THICKENING RIGHT MAXILLARY SINUS. IMPRESSION: NEW AREA OF LOW ATTENUATION IN THE POSTERIOR RIGHT FRONTAL LOBE WITH HIGH ATTENUATION IN THE GYRI IN THIS REGION SUGGESTING ACUTE OR CHRONIC ISCHEMIA AND PETECHIAL CORTICAL HEMORRHAGE POSSIBLY FROM REPERFUSION. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00320 AND 9616099-2013-00321.
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00320 AND 9616099-2013-00321.
THE PATIENT WAS SYMPTOMATIC AT THE TIME OF THE INDEX PROCEDURE. BASELINE NIH STROKE SCALE SCORE WAS 5 AND THE RANKIN SCORE WAS 4. CAS WAS PERFORMED ON A 95% OCCLUDED LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY OF 30MM IN LENGTH IN A 5.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTOUSITY. THE ARCH II LESION WAS ECCENTRIC, ULCERATED AND MODERATELY CALCIFIED. A 5MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS SUCCESSFULLY DEPLOYED PAST THE LESION AND PRE-DILATATION WAS PERFORMED FOLLOWED BY DEPLOYMENT OF A 10X40MM PRECISE PRO RX STENT AND A 10X30MM PRECISE PRO RX STENT, BOTH AT THE TARGET LESION. THE RESIDUAL DIAMETER STENOSIS MEASURED 20%. THE ANGIOGUARD WAS SUCCESSFULLY REMOVED AND THERE WAS NO DEBRIS FOUND IN THE BASKET. THERE WAS NO DOCUMENTED DISSECTION AND NO DOCUMENTED PRESENCE OF AIR BUBBLES. THE PATIENT WAS NEUROLOGICALLY INTACT UPON LEAVING THE ANGIO SUITE. NIH ON THE FOLLOWING DAY WAS 21 AND THE RANKIN SCORE WAS 5. THE PATIENT DIED 21 DAYS LATER. (B)(4). PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00320 AND 9616099-2013-00321.
AS REPORTED BY THE SAPPHIRE REGISTRY THE PATIENT EXPERIENCED BEHAVIOR CHANGE, APHASIA, DYSARTHRIA WITHIN A FEW HOURS AFTER THE INDEX PROCEDURE. THE PHYSICIAN DIAGNOSED THE EVENT AS A REPERFUSION BLEED. 22 DAYS AFTER THE INDEX PROCEDURE THE PATIENT DIED. THE PATIENT IS A PLEASANT (B)(6) OLD GENTLEMAN WHO SUFFERED A RIGHT HEMISPHERIC STROKE EARLY IN (B)(6). HIS HOSPITAL COURSE AT THAT TIME WAS COMPLICATED BY ASPIRATION PNEUMONIA. HE SPENT APPROXIMATELY 6 WEEKS IN REHABILITATION. HE WAS NOTED TO HAVE HIGH-GRADE STENOSIS OF HIS RIGHT CAROTID ARTERY. MOST OF HIS NEUROLOGIC FUNCTION HAD RETURNED TO BASELINE. HE WAS ADMITTED FOR AN ELECTIVE CAROTID STENT PER THE SAPPHIRE STUDY PROTOCOL. HE UNDERWENT STENTING TO HIS RIGHT INTERNAL CAROTID ARTERY. APPROXIMATELY AN HOUR OR SO POST-PROCEDURE HE DEVELOPED A LEFT HEMIPARESIS WITH APHASIA. A STAT HEAD CT SCAN WAS PERFORMED WHICH DEMONSTRATED HIGH ATTENUATION IN THE GYRI OF THE RIGHT FRONTAL LOBE SUGGESTING CORTICAL HEMORRHAGE PROBABLY FROM REPERFUSION. THERE WAS ALSO SOME LOW ATTENUATION IN THE RIGHT POSTERIOR FRONTAL LOBE WHICH MAY OR MAY NOT HAVE BEEN RELATED TO HIS PREVIOUS STROKE IN MARCH. HE WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. HIS NEUROLOGIC FUNCTION DID IMPROVE. THE PATIENT HAS SINCE BEEN ADMITTED TO HOSPICE CARE. THE PATIENT WAS SYMPTOMATIC AT THE TIME OF THE INDEX PROCEDURE. BASELINE NIH STROKE SCALE SCORE WAS 5 AND THE RANKIN SCORE WAS 4. CAS WAS PERFORMED ON A 95% OCCLUDED LESION IN THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY OF 30MM IN LENGTH IN A 5.0MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOSITY. THE ARCH II LESION WAS ECCENTRIC, ULCERATED AND MODERATELY CALCIFIED. MEDICAL HISTORY INCLUDED FIRST-DEGREE RELATIVE WITH PREMATURE CAD HYPERLIPIDEMIA, CLINICAL COPD, HISTORY OF SMOKING (>5PACKS OF CIGARETTES), DIABETES MELLITUS, CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, HYPERTENSION AND PREVIOUS STROKE. (B)(4): DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. (B)(4): PENDING. CEREBRAL HYPERPERFUSION SYNDROME (CHS) AND DEATH ARE KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION SYNDROME (CHS) MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. THERE ARE VARIOUS FACTORS IMPLICATED AS PLAYING A ROLE IN CHS, SUCH AS CEREBRAL AUTOREGULATION, HYPERTENSION, ISCHEMIA REPERFUSION INJURY, INTRAOPERATIVE ISCHEMIA, OXYGEN DERIVED FREE RADICALS AND BARO-RECEPTOR DYSFUNCTION. TRANSIENT CEREBRAL HYPEREMIA CAN LEAD TO SEVERE UNILATERAL HEADACHE, FACE AND EYE PAIN, CONFUSION, SEIZURES, FOCAL NEUROLOGIC DEFICITS, AND INTRACEREBRAL HEMORRHAGES. TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00320 AND 9616099-2013-00321.
ADJUDICATION MINUTES WERE RECEIVED AND NOTED THAT THE NEUROLOGICAL EVENT SUFFERED BY THE PATIENT WAS A STROKE, ISCHEMIC/EMBOLIC IN NATURE AND NOT A REPERFUSION BLEED AS ORIGINALLY REPORTED BY THE SITE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LESION WAS PRE-DILATED WITH A 3.0 X 30-MAVERICK BALLOON. THE ARTERY WAS THEN STENTED WITH A 10.0 X 40-MM AND A 10.0X30-MM PRECISE STENTS. THE STENTS WERE POST-DILATED WITH A 5.0 X 30MM AVIATOR BALLOON. THERE WAS APPROXIMATELY 20% RESIDUAL STENOSIS WITH EXCELLENT ANTEGRADE FLOW. THE INTRACEREBRAL IMAGES WERE UNCHANGED FROM BASELINE, SPECIFICALLY THERE IS NO EVIDENCE OF ATHERO-EMBOLIZATION OR INTRACRANIAL BLEEDING. THE FILTER WAS RETRIEVED WITHOUT DIFFICULTY. THERE IS NO EVIDENCE OF ATHEROEMBOLIZATION SEEN IN THE FILTER UPON VISUAL INSPECTION. THE CATHETERS WERE WITHDRAWN. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS RETURNED TO HIS ROOM IN STABLE CONDITION. WITHIN A FEW HOURS THE PATIENT EXPERIENCED BEHAVIOR CHANGE, APHASIA, DYSARTHRIA. THE PHYSICIAN DIAGNOSED THE EVENT AS A REPERFUSION BLEED. THE BLEED WAS LOCATED AT THE SAME LOCATION OF THE STROKE SUFFERED BY THE PATIENT TWO MONTHS EARLIER. THE PHYSICIAN FOUND THAT IT WAS DIFFICULT TO JUDGE IF THE BLEED WAS NEW OR OLD BUT DETERMINED THAT THE EVENT WAS PROCEDURAL RELATED. A BRAIN CT SCAN ON THE DAY OF THE PROCEDURE, COMPARED TO MRI ON (B)(6) 2013 AND A HEAD CT ON (B)(6) 2013, REVEALED A NEW AREA OF LOW ATTENUATION IN THE POSTERIOR RIGHT FRONTAL LOBE WITH HIGH ATTENUATION IN THE GYRI IN THIS REGION SUGGESTING ACUTE OR CHRONIC ISCHEMIA AND PETECHIAL CORTICAL HEMORRHAGE POSSIBLY FROM REPERFUSION, OR LESS LIKELY SUBARACHNOID HEMORRHAGE. THERE WAS NO INTRA-PARENCHYMAL HEMORRHAGE. THERE WAS NO SIGNIFICANT MASS EFFECT OR MIDLINE SHIFT. THE NEXT DAY THE NIH STROKE SCALE SCORE WAS 21 DUE TO DECREASED LOC (NOT ALERT BUT AROUSABLE), PARTIAL FACIAL PARALYSIS, NO EFFORT AGAINST GRAVITY IN THE LEFT ARM, SOME EFFORT AGAINST GRAVITY IN THE RIGHT ARM, NO EFFORT AGAINST GRAVITY IN THE LEFT LEG AND IN THE RIGHT LEG, ONE LIMB ATAXIA, MILD TO MODERATE SENSORY LOSS, SEVERE APHASIA, SEVERE DYSARTHRIA, AND EXTINCTION AND INATTENTION IN ONE OF SENSORY MODALITIES (IN THE RIGHT LEG). THE RANKIN STROKE SCALE SCORE WAS 5. THE PATIENT WAS TRANSFERRED TO ICU. PER HOSPITAL NOTE, HIS NEUROLOGICAL FUNCTION WAS IMPROVING. HE WAS ABLE TO GRIP WITH HIS LEFT HAND AND REGAINED THE STRENGTH IN HIS LEFT LEG. HIS SPEECH REMAINED "SOMEWHAT DYSARTHRIC." THE SITE REPORTED STROKE (INTRACEREBRAL/SUBARACHNOID HEMORRHAGE). SPEECH THERAPY, OT AND PT WERE CONSULTED, AND SPEECH THERAPY INITIAL ASSESSMENT WAS THAT THE PATIENT WAS PROBABLY ASPIRATING. HE WAS MADE NPO AND NASOGASTRIC TUBE WAS PLACED. HE REMAINED STABLE OVER THE WEEKEND AND MADE PROGRESS NEUROLOGICALLY. A FORMAL SWALLOW STUDY PERFORMED NEXT DAY WAS REPORTED AS ABNORMAL. THE FOLLOWING DAY HE DEVELOPED FEVER UP TO 103 DEGREES AND BECAME LETHARGIC. ASPIRATION PNEUMONIA WAS SUSPECTED, AND PULMONOLOGY SERVICE WAS CONSULTED. HE WAS STARTED ON ANTIBIOTICS AND WAS PLACED ON BIPAP. FOLLOWING DAY HIS FEVER RESOLVED AND HE CONTINUED IMPROVING NEUROLOGICALLY. HIS OXYGEN WAS ABLE TO BE WEANED OFF TO NASAL CANNULA. THE PATIENT AGAIN DEVELOPED FEVERS WITH LOW OXYGEN SATURATION FIVE DAYS POST PROCEDURE. PULMONARY CONSULTATION REPORTED ACUTE HYPOXIC RESPIRATORY FAILURE WITH QUESTION WHETHER THIS WAS DUE TO POSSIBLE ASPIRATION PNEUMONIA. CONTINUATION OF BIPAP WAS RECOMMENDED WITH NO TRANSFER TO ICU AT THAT TIME AS THE PATIENT HAD A DO NOT RESUSCITATE ORDER. THE PATIENT WAS TRANSFERRED TO HOSPICE CARE AND DIED TWENTY ONE DAYS POST INDEX PROCEDURE. THE SITE REPORTED THE CAUSE OF DEATH AS UNKNOWN. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00320 AND 9616099-2013-00321.
ADJUDICATION MINUTES NOTED THAT THE NEUROLOGICAL EVENT SUFFERED BY THE PATIENT WAS A STROKE, ISCHEMIC/EMBOLIC IN NATURE AND NOT A REPERFUSION BLEED AS ORIGINALLY REPORTED BY THE SITE. INFORMATION RECEIVED STATES THAT THE RIGHT INTERNAL CAROTID LESION WAS PRE-DILATED WITH A 3.0 X 30-MAVERICK BALLOON. THE ARTERY WAS THEN STENTED WITH A 10.0 X 40-MM AND A 10.0X30-MM PRECISE STENTS. THE STENTS WERE POST-DILATED WITH A 5.0 X 30MM AVIATOR BALLOON. THERE WAS APPROXIMATELY 20% RESIDUAL STENOSIS WITH EXCELLENT ANTEGRADE FLOW. THE INTRACEREBRAL IMAGES WERE UNCHANGED FROM BASELINE; SPECIFICALLY THERE IS NO EVIDENCE OF ATHERO-EMBOLIZATION OR INTRACRANIAL BLEEDING. THE FILTER WAS RETRIEVED WITHOUT DIFFICULTY. THERE IS NO EVIDENCE OF ATHEROEMBOLIZATION SEEN IN THE FILTER UPON VISUAL INSPECTION. THE CATHETERS WERE WITHDRAWN. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS RETURNED TO HIS ROOM IN STABLE CONDITION. WITHIN A FEW HOURS THE PATIENT EXPERIENCED BEHAVIOR CHANGE, APHASIA, DYSARTHRIA. THE PHYSICIAN DIAGNOSED THE EVENT AS A REPERFUSION BLEED. THE BLEED WAS LOCATED AT THE SAME LOCATION OF THE STROKE SUFFERED BY THE PATIENT TWO MONTHS EARLIER. THE PHYSICIAN FOUND THAT IT WAS DIFFICULT TO JUDGE IF THE BLEED WAS NEW OR OLD BUT DETERMINED THAT THE EVENT WAS PROCEDURAL RELATED. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ISCHEMIC STROKE IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CAROTID STENT IMPLANTATION PROCEDURE. 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. THERE IS NO EVIDENCE THAT MANUFACTURING ISSUES CONTRIBUTED TO THE EVENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00320 AND 9616099-2013-00321.
AS REPORTED BY (B)(6), THE PATIENT EXPERIENCED BEHAVIOR CHANGE, APHASIA, DYSARTHRIA WITHIN A FEW HOURS AFTER THE INDEX PROCEDURE. THE PHYSICIAN DIAGNOSED THE EVENT AS A REPERFUSION BLEED. PLEASE NOTE THAT MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT AND REPORTED EVENT HAVE BEEN MADE AND THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL. THE PRODUCTS WERE NOT RETURNED FOR EVALUATION AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. CEREBRAL HYPERPERFUSION SYNDROME (CHS) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CAROTID STENTS. AFTER REVASCULARIZATION THAT ALLEVIATES A HIGH-GRADE SYMPTOMATIC STENOTIC LESION, CEREBRAL HYPERPERFUSION SYNDROME (CHS) MAY OCCUR AS A RESULT OF A SUDDEN, RAPID INCREASE IN CEREBRAL BLOOD FLOW EXCESS OF THAT REQUIRED TO MEET METABOLIC DEMANDS. THERE ARE VARIOUS FACTORS IMPLICATED AS PLAYING A ROLE IN CHS, SUCH AS CEREBRAL AUTOREGULATION, HYPERTENSION, ISCHEMIA REPERFUSION INJURY, INTRAOPERATIVE ISCHEMIA, OXYGEN DERIVED FREE RADICALS AND BARO-RECEPTOR DYSFUNCTION. TRANSIENT CEREBRAL HYPEREMIA CAN LEAD TO SEVERE UNILATERAL HEADACHE, FACE AND EYE PAIN, CONFUSION, SEIZURES, FOCAL NEUROLOGIC DEFICITS, AND INTRACEREBRAL HEMORRHAGES. TYPICALLY, INTRACEREBRAL HEMORRHAGE DEVELOPS ON THE THIRD TO FIFTH POSTOPERATIVE DAY, THOUGH THERE HAVE BEEN CASES OBSERVED IMMEDIATELY AFTER SURGERY, AS WELL AS CASES DEVELOPED 3 WEEKS AFTER REVASCULARIZATION. THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT BUT VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF TWO PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00320 AND 9616099-2013-00321.
AS REPORTED BY THE SAPPHIRE REGISTRY THE PATIENT EXPERIENCED BEHAVIOR CHANGE, APHASIA, DYSARTHRIA WITHIN A FEW HOURS AFTER THE INDEX PROCEDURE. THE PHYSICIAN DIAGNOSED THE EVENT AS A REPERFUSION BLEED. PLEASE NOTE THAT MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE PATIENT AND REPORTED EVENT AND THESE ATTEMPTS HAVE BEEN UNSUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232152 | PRECISE PRO RX CAROTID STENT SYSTEM | SELF EXPANDING STENTS (NIM) | NIM | CORDIS DE MEXICO | NA | 15772435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death| H| L| R |