Catalog Number PC0930RXC |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Death (1802)
|
Event Date 01/18/2014 |
Event Type
Death
|
Event Description
|
As reported by the sapphire registry, the patient died in her sleep the day after discharge from the hospital after having a precise pro rx stent implantation procedure.No autopsy done and there was limited information.The target lesion was located in the bifurcation of the right common carotid artery with a length of 40mm and a reference diameter of 8mm.The eccentric lesion was mildly calcified in a concentric manner with 80% stenosis.There was no lesion thrombosis.The vessel was a type i arch vessel with mild tortuosity.The nih and rankin stroke scale score were both 0 at baseline, and the patient was asymptomatic before the procedure.Approach was made with a 5mm angioguard rx embolic protection device, which was deployed past the lesion before pre-dilation was preformed.Then, a 9x30mm precise pro rx stent was implanted at the target lesion, leaving a final stenosis rate of 10%.The angioguard was removed and found to have no debris n the basket.There was none documented presence of air bubbles and the patient did not have a neurological deficit prior to leaving the angiography suite.The patient was discharged 2 days later with an nih and rankin score of 0.When attempting to contact the patient for the 30-day follow-up, it was reported that the patient died in her sleep the day after discharge.An autopsy was no done and there was limited information.The cause or suspected cause of death is currently unknown.This event was reported not related to the cordis device or index procedure.
|
|
Manufacturer Narrative
|
The device remains implanted in the patient; therefore the device will not be returned for analysis.A device history record (dhr) review could not be conducted without a lot number provided.Additional information is pending and will be submitted within 30 days upon receipt.The catalog code provided (pxxxrx), represents an unknown precise stent.The catalog and lot numbers for the actual product implanted in the patient are unknown.Concomitant medications: heparin was given during the procedure.Pre and post-procedure medications included aspirin and clopidogrel.Concomitant devices: 5mm angioguard rx, lot and catalog numbers are unknown.
|
|
Manufacturer Narrative
|
A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information was provided: the target lesion length was 10mm.The cause of death after discussion with the doctors is unknown, "and we can put it as natural cause of death." complaint conclusion: as reported by the sapphire registry, the patient died in her sleep the day after discharge from the hospital after having a precise pro rx stent implantation procedure.No autopsy done and there was limited information.The patient was a (b)(6) female with a medical history of severe aortic / mitral valve disease, diabetes mellitus, hypertension, and chf (class iii/iv) and/or known severe left ventricular dysfunction lvef<35%.The target lesion was located in the bifurcation of the right common carotid artery with a length of 10mm and a reference diameter of 8mm.The eccentric lesion was mildly calcified in a concentric manner with 80% stenosis.There was no lesion thrombosis.The vessel was a type i arch vessel with mild tortuosity.The nih and rankin stroke scale score were both 0 at baseline, and the patient was asymptomatic before the procedure.Approach was made with a 5mm angioguard rx embolic protection device, which was deployed past the lesion before pre-dilation was preformed.Then, a 9x30mm precise pro rx stent was implanted at the target lesion, leaving a final stenosis rate of 10%.The angioguard was removed and found to have no debris n the basket.There was none documented presence of air bubbles and the patient did not have a neurological deficit prior to leaving the angiography suite.The patient was discharged 2 days later with an nih and rankin score of 0.When attempting to contact the patient for the 30-day follow-up, it was reported that the patient died in her sleep the day after discharge.An autopsy was not done and there was limited information.The cause or suspected cause of death is currently unknown.This event was reported not related to the cordis device or index procedure.The cause of death after discussion with the doctors is unknown, "and we can put it as natural cause of death." the device remained implanted in the patient; therefore, it was not available for analysis.A device history record (dhr) 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 15667715 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Death is a known potential adverse event associated with the precise pro rx stent implantation and is listed in the ifu as such.The cause of the death was unknown, therefore it is unknown if the death was neurological or cardiac-related.Based on the limited information available for review, the patient¿s medical conditions of severe aortic / mitral valve disease, chf (class iii/iv) and/or known severe left ventricular dysfunction lvef<35%, diabetes mellitus, and hypertension may have contributed to the death reported.With the limited amount of information available and without an autopsy provided, it is not possible to draw a clinical conclusion between the device and the reported event.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported event does not appear to be related to the manufacturing process of the device.
|
|
Manufacturer Narrative
|
Adjudication minutes on the event were received.The clinical events committee (cec) agreed that a "death, neurologic" occurred and was procedure and device-related.Additional details were received from the clinical events committee (cec) meeting minutes: the site tried to contact the patient for a 30-day follow-up visit.In response, they received a letter from her daughter, in which she informed that the patient passed away in her sleep.She seemed just fine that night before as she went to bed, although she did have extensive bruising on her right side from the procedure.No autopsy was done, ¿we just accepted that this was a blood clot or other complication from the procedure¿; this was unexpected for her friends and family.The site reported the cause of death as unknown.Complaint conclusion: as reported by (b)(6), the patient died in her sleep the day after discharge from the hospital after having a precise pro rx stent implantation procedure.No autopsy done and there was limited information.The patient was a (b)(6) female with a medical history of severe aortic / mitral valve disease, diabetes mellitus, hypertension, and chf (class iii/iv) and/or known severe left ventricular dysfunction lvef<35%.The target lesion was located in the bifurcation of the right common carotid artery with a length of 10mm and a reference diameter of 8mm.The eccentric lesion was mildly calcified in a concentric manner with 80% stenosis.There was no lesion thrombosis.The vessel was a type i arch vessel with mild tortuosity.The nih and rankin stroke scale score were both 0 at baseline, and the patient was asymptomatic before the procedure.Approach was made with a 5mm angioguard rx embolic protection device, which was deployed past the lesion before pre-dilation was preformed.Then, a 9x30mm precise pro rx stent was implanted at the target lesion, leaving a final stenosis rate of 10%.The angioguard was removed and found to have no debris n the basket.There was none documented presence of air bubbles and the patient did not have a neurological deficit prior to leaving the angiography suite.The patient was discharged 2 days later with an nih and rankin score of 0.When attempting to contact the patient for the 30-day follow-up, it was reported that the patient died in her sleep the day after discharge.The cause or suspected cause of death is currently unknown; however it was post-adjudicated as neurological-related.This event was reported not related to the cordis device or index procedure.It was reported that she seemed just fine that night before as she went to bed, although she did have extensive bruising on her right side from the procedure.No autopsy was done, ¿we just accepted that this was a blood clot or other complication from the procedure¿; this was unexpected for her friends and family.The device remained implanted in the patient; therefore, it was not available for analysis.A device history record (dhr) 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 15667715 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Death is a known potential adverse event associated with the precise pro rx stent implantation and is listed in the ifu as such.The cause of the death was unknown, therefore it is unknown if the death was neurological or cardiac-related.Based on the limited information available for review, the patient¿s medical conditions of severe aortic / mitral valve disease, chf (class iii/iv) and/or known severe left ventricular dysfunction lvef<35%, diabetes mellitus, and hypertension may have contributed to the death reported.The bruising reported by the patient¿s family is a well known potential adverse event associated with an intravascular procedure such as carotid stenting and is listed in the ifu as such.The bruising reported could be associated with any device used during the procedure, especially with stick technique, anticoagulation, blood pressure, adequate sheath removal technique and patient's compliance to decrease mobility of limb affected in order to promote coagulation.Patient and/or pharmacological factors are likely contributing factors.With the limited amount of information available and without an autopsy provided, it is not possible to draw a clinical conclusion between the device and the reported event.No corrective or preventive action will be taken, given that; with the dhr and the information provided, the reported event does not appear to be related to the manufacturing process of the device.
|
|
Search Alerts/Recalls
|
|