| Model Number GELWEAVE VALSALVA |
| Device Problems
Patient-Device Incompatibility (2682); Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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| Patient Problems
Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Asystole (4442)
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| Event Date 02/18/2021 |
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Event Type
Death
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Manufacturer Narrative
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No patient information provided device location unknown - hospital enquired about transport medium for device but no further information received on device location.(b)(4) asystole - it was reported that patient in intensive care went into sudden cardio-respiratory arrest (asystole) without prodrome.(b)(4) - thrombosis/thrombus - postoperatively, the practitioner observes on transesophageal ultrasound the presence of a thrombus molding the wall of the tube of the vascular prosthesis reaching the aortic valve without obstruction of the blood flow visible at the doppler.(b)(4) - obstruction / occlusion - on (b)(6) 2021, faced with a deficit in the upper left limb, the practitioner observed a vascular accident in the right sylvian territory compatible with the clinic and the reappearance of a large aortic thrombus obstructing the right coronary.(b)(4) - one or more surgical procedures were required, or an existing procedure changed.(b)(4) - additional surgery - surgical intervention was required twice.Patient is taken back to the operating room on (b)(6) 2021 for thrombus removal.During the procedure on patient is put on extracorporeal circulation (ecb).The practitioner then proceeds to wash the numerous clots present on the wall of the artificial ascending aorta.And additionally, on (b)(6) 2021, another return to the operating room for thrombus removal.(b)(4) - the cessation of life.- the patient died on (b)(6) 2021 patient device interaction problem - problem related to the interaction between the patient and the device.Patient-device incompatibility - problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device.Biocompatibility - patient has had a reaction to the implant of the edwards valve or gelweave valsalva graft that led to thrombus formation on inner wall of graft.Adverse event without identified device or use problem - the gelweave valsalva device is designed to be used in conjunction with a biological valve and as such there was no issue with this procedure.From information received there does not appear to have been any issue with the procedure to implant the device however there is no information or images to confirm this.Part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or sub-assemblies, or it would not be appropriate to link the reported incident to a single part, component, or sub-assembly.- the valsalva graft is manufactured from a single woven tube of material and as such does not contain any sub-assemblies or additional component parts.Type of investigation: historical data analysis - a five-year review of similar reported events for gelweave valsalva grafts for occlusion and death were reviewed and found 2 previous events giving an occurrence rate of (b)(4) (complaints v sales).Analysis if production records - qc, manufacturing and physical test records of base material were retrieved and reviewed and show batch was manufactured to design specification and all tests met acceptance criteria.Communication/interviews further information on event was requested from distributor and from site however no additional information was received at time f this report submission to assist in investigation of this event.Device not returned - the actual device involved in the adverse event was not returned for testing despite requests by manufacturer.- although it was indicated that device was explanted at facility no further information has been received as to the disposition of this device.Investigation findings: no device problem found - no issue has been found on review of device history records of any issue with the manufacture of this device.Results pending completion of investigation - investigation is ongoing and results are not yet available - vascutek is awaiting further information and/or images from site to further investigate this complaint however no further information has been received at time of this submission.Investigation conclusions: conclusion not yet available - a conclusion has yet to be established as the investigation is incomplete - vascutek is awaiting further information from site and will report findings in next follow up / final report.
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Event Description
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Vascutek ltd.Was initially contacted on 25-feb-21 by (b)(6) distributor of a request from a hospital for information on preservation of an explanted gelweave graft from a procedure where the patient died.Further information was requested and on 03-mar-21 further information was received in the form of the report submitted by the hospital to ansm with a rough english translation provided by the distributor.No notification of the event was received by vascutek ltd.Prior to notification to distributor by ansm.The event was reported to ansm as follows: date : (b)(6) 2021, by : mrs (b)(6), for gelweave valsalva 30 mm diam.Patient clinical status: death.Device explanted for expertise.Circumstances / description of facts: on (b)(6) 2021, the patient was hospitalized for heart surgery for an ascending aortic replacement as well as the aortic valve.The practitioner performs bentall surgery and implants: a valsava vascular prosthesis from the supplier vascutek france (ref: 730030adp, batch number:21513568 - 3559, serial number: (b)(4)); and an inspiris 25 mm biological aortic valve from the supplier edwards (ref: 11500a25, number of series: (b)(4)).On (b)(6) 2021, in intensive care, the patient went into sudden cardio-respiratory arrest (asystole) without prodrome.At transthoracic ultrasound, the practitioner notes the absence of tamponade.He succeeded in resuscitating the patient after 50 min of low-flow, 10 mg of adrenaline and 2 external electric shocks and an ecmo (oxygenation by membrane extracorporeal) venous / arterial.Postoperatively, the practitioner observes on transesophageal ultrasound the presence of a thrombus molding the wall of the tube of the vascular prosthesis reaching the aortic valve without obstruction of the blood flow visible at the doppler.In this context, the patient is taken back to the operating room on (b)(6) 2021 for thrombus removal.During the procedure on patient is put on extracorporeal circulation (ecb).The practitioner then proceeds to wash the numerous clots present on the wall of the artificial ascending aorta.No dysfunction of the cec was noted.At the end of the procedure, the patient is placed on antibiotic prophylaxis with vancomycin and cefuroxime and the practitioner puts the patient back on ecmo (extracorporeal membrane oxygenation).The patient is then transferred to the intensive care unit for further treatment.On (b)(6) 2021, another return to the operating room for thrombus removal.On (b)(6) 2021, faced with a deficit in the upper left limb, the practitioner observed a vascular accident in the right sylvian territory compatible with the clinic and the reappearance of a large aortic thrombus obstructing the right coronary.The patient died on (b)(6) 2021.Current location of explanted device is unknown as no response to request for further information.
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Manufacturer Narrative
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No patient information provided.Device location unknown - hospital enquired about transport medium for device but no further information received on device location.Health effect - clinical code: asystole - it was reported that patient in intensive care went into sudden cardio-respiratory arrest (asystole) without prodrome.Thrombosis/thrombus - postoperatively, the practitioner observes on transesophageal ultrasound the presence of a thrombus molding the wall of the tube of the vascular prosthesis reaching the aortic valve without obstruction of the blood flow visible at the doppler.Obstruction / occlusion - on (b)(6) 2021, faced with a deficit in the upper left limb, the practitioner observed a vascular accident in the right sylvian territory compatible with the clinic and the reappearance of a large aortic thrombus obstructing the right coronary.Health impact - impact code: one or more surgical procedures were required, or an existing procedure changed.Additional surgery - surgical intervention was required twice.Patient is taken back to the operating room on (b)(6) 2021 for thrombus removal.During the procedure on patient is put on extracorporeal circulation (ecb).The practitioner then proceeds to wash the numerous clots present on the wall of the artificial ascending aorta.And additionally, on (b)(6) 2021, another return to the operating room for thrombus removal.1802 - the cessation of life.- the patient died on 02/21/2021 medical device problem code: patient device interaction problem - problem related to the interaction between the patient and the device.Patient-device incompatibility - problem associated with the interaction between the patient's physiology or anatomy and the device that affects the patient and/or the device.Biocompatibility - patient has had a reaction to the implant of the edwards valve or gelweave valsalva graft that led to thrombus formation on inner wall of graft.Adverse event without identified device or use problem - the gelweave valsalva device is designed to be used in conjunction with a biological valve and as such there was no issue with this procedure.From information received there does not appear to have been any issue with the procedure to implant the device however there is no information or images to confirm this.Component code: part/component/sub-assembly term not applicable - the device does not have distinct parts, components, or sub-assemblies, or it would not be appropriate to link the reported incident to a single part, component, or sub-assembly.- the valsalva graft is manufactured from a single woven tube of material and as such does not contain any sub-assemblies or additional component parts.Type of investigation: historical data analysis - a five-year review of similar reported events for gelweave valsalva grafts for occlusion and death were reviewed and found 2 previous events giving an occurrence rate of (b)(4) (complaints v sales).Analysis if production records - qc, manufacturing and physical test records of base material were retrieved and reviewed and show batch was manufactured to design specification and all tests met acceptance criteria.Communication/interviews further information on event was requested from distributor and from site however no additional information was received at time f this report submission to assist in investigation of this event.Device not returned - the actual device involved in the adverse event was not returned for testing despite requests by manufacturer.- although it was indicated that device was explanted at facility no further information has been received as to the disposition of this device.Investigation findings: no device problem found - no issue has been found on review of device history records of any issue with the manufacture of this device.Investigation conclusions: the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Review of the device history records and qc and physical testing records show that device was manufactured to design specification.Despite numerous attempts to retrieve further information and scans or images from site no further information was received, location of the explanted device was also no reported to vascutek ltd.And therefore no further investigation was possible.Vascutek ltd.Now considers this complaint closed.Further action is not planned, however, the issue will be tracked and trended as part of the on-going complaints trending and reporting process and if an adverse trend develops action may be taken at that time.
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Event Description
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Vascutek ltd.Was initially contacted on (b)(6) 21 by (b)(6) distributor of a request from a hospital for information on preservation of an explanted gelweave graft from a procedure where the patient died.Further information was requested and on (b)(6) 2021 further information was received in the form of the report submitted by the hospital to (b)(6) with a rough english translation provided by the distributor.No notification of the event was received by vascutek ltd.Prior to notification to distributor by (b)(6).The event was reported to (b)(6) as follows: date : (b)(6) 2021.By : mrs (b)(6).For gelweave valsalva 30 mm diam.Patient clinical status: death.Device explanted for expertise.Circumstances / description of facts: on (b)(6) 2021, the patient was hospitalized for heart surgery for an ascending aortic replacement as well as the aortic valve.The practitioner performs bentall surgery and implants: a valsava vascular prosthesis from the supplier vascutek (b)(6) (ref: 730030adp, batch number:21513568 - 3559, serial number: (b)(4)) and an inspiris 25 mm biological aortic valve from the supplier edwards (ref: (b)(4), number of series: (b)(4)) on (b)(6) 2021, in intensive care, the patient went into sudden cardio-respiratory arrest (asystole) without prodrome.At transthoracic ultrasound, the practitioner notes the absence of tamponade.He succeeded in resuscitating the patient after 50 min of low-flow, 10 mg of adrenaline and 2 external electric shocks and an ecmo (oxygenation by membrane extracorporeal) venous / arterial.Postoperatively, the practitioner observes on transesophageal ultrasound the presence of a thrombus molding the wall of the tube of the vascular prosthesis reaching the aortic valve without obstruction of the blood flow visible at the doppler.In this context, the patient is taken back to the operating room on (b)(6) 2021 for thrombus removal.During the procedure on patient is put on extracorporeal circulation (ecb).The practitioner then proceeds to wash the numerous clots present on the wall of the artificial ascending aorta.No dysfunction of the cec was noted.At the end of the procedure, the patient is placed on antibiotic prophylaxis with vancomycin and cefuroxime and the practitioner puts the patient back on ecmo (extracorporeal membrane oxygenation).The patient is then transferred to the intensive care unit for further treatment.On (b)(6) 2021, another return to the operating room for thrombus removal.On (b)(6) 2021, faced with a deficit in the upper left limb, the practitioner observed a vascular accident in the right sylvian territory compatible with the clinic and the reappearance of a large aortic thrombus obstructing the right coronary.The patient died on (b)(6) 2021.Current location of explanted device is unknown as no response to request for further information.
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