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Model Number 9610ES14 |
Device Problems
Difficult or Delayed Positioning (1157); Peeled/Delaminated (1454); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)
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Patient Problems
Obstruction/Occlusion (2422); Vascular Dissection (3160); Paresthesia (4421)
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Event Date 02/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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The investigation is in progress.A supplemental report will be submitted upon completion.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2022-04875.
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Event Description
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Edwards received notification from our affiliate in (b)(6).As reported, a female underwent an implant of a 26 mm sapien 3 ultra valve, in aortic position by transfemoral approach.The access was difficult due to severe calcification and kinking, in total the sheath had to be changed two times due to kinking and impossibility of valve passage, also a valve stuck in the destroyed sheath had to be discarded.With pre-expansion of the iliac vessels with 5 and 6mm balloons and use of the lundaquist, the passage of the valve prosthesis through the sheath finally succeeded with great effort and can finally be implanted successfully with a good primary result.Furthermore, a mottled, cold and pulseless right lower extremity was detected, so that a ct+cta was quickly performed.This showed occlusion of the distal external iliac artery, and the right lower extremity was not perfused except for an intact profundal femoral artery.In the area of the arterial puncture on the right side, there was no evidence of any complications such as aneurysm spurium or av fistula or active bleeding.After verification of a right iliac artery occlusion as the cause of the arterial occlusion by ct examination, the patient was immediately transferred to the operating room.As per medical opinion, the main cause of the occlusion was a known severe pavk and kinking of the aorta.Was caused by the first esheath.The massively calcified and dissected vessel (afc) was resected and the creation of a crossover bypass was performed.Postoperatively, all peripheral pulses can be derived laterally and vigorously in both legs.As per medical opinion, the crossover bypass is open, the feet are warm on both sides; there is no evidence for a compartment syndrome; the wounds are bland; the big toe on the right side is paresthetic; otherwise inconspicuous.Specific blood thinning for bypass were not required.
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Manufacturer Narrative
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The device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The complaints of resistance between system components/inability to advance through sheath and sheath kinked/bent were unable to be confirmed without the returned device or procedural imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.The training manual states, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.'' the complaint description states, ''the access was difficult due to severe calcification and kinking''.Tortuosity (or 'kinking') and severe calcification can create a challenging pathway for device insertion resulting in suboptimal angles to navigate.If any resistance was experienced in attempts to overcome a difficult pathway, the sheath could kink due to high push force.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the reported resistant and procedural factors (high push force) may have caused the sheath to kink.No labeling/ifu deficiencies were identified.A product risk assessment (pra) has been previously initiated to capture the product risk assessment and a capa was previously initiated to capture further investigation and corrective/preventative activities.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.According to the literature review, and as documented in a technical summary written by edwards lifesciences, vascular complications are a well-recognized complication of the transfemoral thv procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications.Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien valve can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.Despite the best screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices.In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.Per the instructions for use (ifu), arterial occlusion is a potential adverse event associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest patient factors as peripheral arterial occlusive disease and kinking of the aorta caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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Manufacturer Narrative
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Supplemental report submitted to correct h10 and add additional codes to h6: the device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.During the manufacturing process, the device was visually inspected and tested several times.All the inspections are conducted on 100% of units, except in the case of product verification (pv) testing, where the tested units are chosen on a sampling basis.All tested sample units for this lot passed pv testing.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.The complaints resistance between system components/inability to advance through sheath, sheath kinked, bent, sheath liner torn were unable to be confirmed without the returned device or procedural imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.A review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.The training manual states, ''push force can vary due to angle of insertion, vessel diameter, tortuosity and degree of calcification.'' the complaint description states, ''the access was difficult due to severe calcification and kinking''.Tortuosity (or 'kinking') and severe calcification can create a challenging pathway for device insertion resulting in suboptimal angles to navigate.If any resistance was experienced in attempts to overcome a difficult pathway, the sheath damage could occur in the form of the alleged shaft kink or liner tear due to high push force and valve interaction with the sheath.Additionally, interaction of the sheath liner with severe calcification can weaken its integrity and result in tearing.However, the type of sheath damage could not be confirmed without the returned device or device imagery.As such, available information suggests that patient factors (tortuosity, calcification) may have contributed to the reported resistant, procedural factors (high push force) may have caused the sheath to kink, patient/procedural factors (calcification, high push force, valve interaction with the sheath).A product risk assessment (pra) has been previously initiated to capture the product risk assessment and a capa was previously initiated to capture further investigation and corrective/preventative activities.Per the instructions for use (ifu), cardiovascular injuries such as perforation or dissection of vessels, ventricle, myocardial or valvular structures are known potential risks or adverse events associated with the overall thv procedure and may require intervention.According to the literature review, and as documented in a technical summary written by edwards lifesciences, vascular complications are a well-recognized complication of the transfemoral thv procedure in this elderly population with multiple co-morbidities.Edwards has reviewed many reports, including screening data records and source documentation of vascular complications, and has found that the root cause is typically related to a combination of vessel size, tortuosity, and calcifications.Although the incidence is decreasing with smaller sheath/delivery system sizes and physician experience, there will continue to be cases in which vascular complications will occur.The thv physician training manuals instruct on procedural considerations for sheath insertion with regards to proper screening critical to reducing vascular complications.The training manual instructs the operator on proper sheath insertion and withdrawal techniques, including pre-dilating the vessel with the edwards dilators, as needed.It also notes that calcification may reduce lumen diameter and limit or prevent the transfemoral passage of the devices.The ifu contraindicates patients with ilio-femoral vessel characteristics that would preclude safe placement of sheaths such as severe obstructive calcification or severe tortuosity.Pre-procedure screening and assessment of the femoral/iliac artery internal diameters will enable the clinician to determine if the sapien valve can be delivered transfemorally.Assessment of location and amount of circumferential calcium will aid in determining areas of reduced vessel diameters.The operators are trained to measure minimum vessel diameter taking calcium into account.The physician training manual also lists the minimum recommended vessel size for each size device.Despite the best screening tools, a small percentage of patients will have femoral/iliac vessels that are not amenable to the trans-femoral approach or where increased resistance is encountered during insertion of devices.In many cases, the vessel minimum luminal diameter (mld) may be borderline or below the indicated size.In addition, significant calcification and/or tortuosity, not always appreciable on imaging, could be contributing factors to the event.Per the instructions for use (ifu), arterial occlusion and dissection are a potential adverse events associated with the transcatheter valve replacement (tvr) procedure and the use of the edwards thv devices.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest patient factors as peripheral arterial occlusive disease and kinking of the aorta caused or contributed to this event.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of this adverse event is not required at this time.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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Search Alerts/Recalls
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