MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; INTRODUCER, CATHETER

Model Number 9610ES16

Device Problems Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

Patient Problem Vascular Dissection (3160)

Event Date 07/11/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted upon completion.Device was discarded.

Event Description

Edwards received notification from our affiliate in germany.As reported, this was a case of an implant of 29 mm edwards sapien 3 transcatheter heart valve, in the aortic position by transfemoral approach.During the procedure, while introducing the delivery system through the esheath, very high push force was noticed.A cine was taken from the femoral artery and esheath damage was noted with the crimped valve pushing through the esheath seam.The system was removed as a single unit and a new system was used successfully.The femoral artery was dissected and required a repair with 3 covered stents.The final outcome of the patient was good.As per medical opinion, the root cause of the event might be related to a combination of tortuosity and lack of stiffness of the guidewire.

Manufacturer Narrative

The device was not returned for evaluation as it was remained implanted/discarded.Therefore, a no product return engineering evaluation was performed.Returned imagery was evaluated and the following was observed: the esheath has a curvature to it.The strain relief was wrinkled.The valve stuck and exposed through sheath torn liner.Tortuosity was seen in patient's access vessels.Calcification was seen in patient's access vessels.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.The complaints for inability to advance through sheath and sheath liner torn were confirmed through returned procedural imagery.As the device was not returned, no visual inspection, functional testing, or dimensional analysis was able to be performed.As such, a manufacturing non-conformance was unable to be determined.However, review of the dhr provided no indication that manufacturing nonconformance was a contributing factor.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device preparation or unpacking.As reported, ''during procedure, while introducing commander through esheath very high push force was noticed.A cine was taken from the femoral artery and a esheath splice was noted with the crimped valve pushing through the esheath seam.System was removed as a single unit and a new system was used successfully.Femoral artery was dissected likely caused by the esheath split, which required a repair with 3 covered stents at the end of the procedure.'' for the complaint of inability to advance through sheath, a detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in an edwards' technical summary.The technical summary provides details of contributing factors for increased resistance during the insertion and advancement of the delivery system through the sheath.The following vessel characteristics and procedural factors were identified as the root causes for encountering increased resistance: tortuous vessels can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.Tortuous vessels were seen in patient's access vessels.The sheath also had a curvature to it, indicative of tortuosity.Calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Calcification was seen in the patient's access vessels.Undersized vessel (<6.0mm for 16f esheath) can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Undersized vessels were not seen in returned patient imagery.Steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.No information was provided about the insertion angle.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with an esheath resistance with delivery system.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.In addition, follow-up information stated that ''lack of stiffness of the guidewire used (amplatz extra stiff)'' could also potentially be a factor in the inability to advance.Per the ifu/training manual, ''use of a stiff wire (for peripheral access only) can be used in cases with peripheral tortuosity (for example, supracore or lunderquist).This method may be utilized for straightening the vessel anatomy for access''.A stiffer wire could assist in straightening out the tortuous anatomy.As such, available information suggests that patient factors (calcification, tortuosity) and procedural factors (guidewire not stiff enough) may have contributed to the reported event.For the complaint of sheath liner torn, an existing edwards' technical summary has been documented for root cause analysis on sheath shaft liner tears with normal liner expansion.The technical summary provides details of contributing factors for sheath shaft liner tears.The following patient and procedural factors were identified as contributing factors for sheath shaft liner tears: tortuous patient anatomy can create sub-optimal angles that can lead to nonaxial alignment in the advancement and retrieval of the delivery system.The delivery system or balloon catheter can potentially catch on to the tip or liner of the sheath and create tip damage or liner tears upon advancement.Tortuous anatomy was reported to be present in the patient's access vessels and was seen in returned patient imagery.The sheath also had a curvature to it, indicative of tortuosity.Calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tear or could weaken the liner.A weakened liner can tear during advancement or retrieval of the delivery system.Calcification was seen in the returned patient imagery.Incomplete deflation of the compatible balloon device prior to removal from the sheath can damage the liner.A balloon burst or tear could also make it difficult to deflate the balloon and would alter the balloon profile during removal.The force required to withdraw the balloon could then lead to tearing or weakening of the sheath liner.No incomplete deflation or balloon burst/tear was noted.The technical summary demonstrated that there were no deficiencies in the ifu/training manuals and also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with sheath shaft liner tears.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.It should be noted that these mitigations (from manufacturing and the ifu/training manual), as identified in the technical summary, are still in place.As such, these inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.No labeling or ifu inadequacies have been identified.Since no edwards defect was identified, no corrective or preventative action is required.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.

Manufacturer Narrative

Supplemental report submitted to correct h10: the device was not returned for evaluation as it was discarded.Therefore, a no product return engineering evaluation was performed.Returned imagery was evaluated and the following was observed: the esheath has a curvature to it.The strain relief was wrinkled.The valve stuck and exposed through sheath torn liner.Tortuosity was seen in patient's access vessels.Calcification was seen in patient's access vessels.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.The complaints for inability to advance through sheath and sheath liner punctured were confirmed through returned procedural imagery.As the device was not returned, no visual inspection, functional testing, or dimensional analysis was able to be performed.As such, a manufacturing non-conformance was unable to be determined.However, review of the dhr provided no indication that manufacturing nonconformance was a contributing factor.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device preparation or unpacking.As reported, ''during procedure, while introducing commander through esheath very high push force was noticed.A cine was taken from the femoral artery and a esheath splice was noted with the crimped valve pushing through the esheath seam.System was removed as a single unit and a new system was used successfully.Femoral artery was dissected likely caused by the esheath split, which required a repair with 3 covered stents at the end of the procedure.'' for the complaint of inability to advance through sheath, a detailed root cause analysis for similar returned sheath shaft resistance with delivery system complaints has been conducted and summarized in an edwards' technical summary.The technical summary provides details of contributing factors for increased resistance during the insertion and advancement of the delivery system through the sheath.The following vessel characteristics and procedural factors were identified as the root causes for encountering increased resistance: tortuous vessels can create sub-optimal angles that can lead to non-axial alignment in the advancement of the delivery system.Tortuous vessels were seen in patient's access vessels.The sheath also had a curvature to it, indicative of tortuosity.Calcification can reduce the vessel diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Calcification was seen in the patient's access vessels.Undersized vessel (<6.0mm for 16f esheath) can create a restricted pathway or constrained condition resulting in difficulty during sheath expansion, thereby increased resistance.Undersized vessels were not seen in returned patient imagery.Steep insertion angle can result in non-coaxial alignment between the delivery system and sheath, which may lead to resistance during advancement.No information was provided about the insertion angle.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with an esheath resistance with delivery system.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.These inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.In addition, follow-up information stated that ''lack of stiffness of the guidewire used (amplatz extra stiff)'' could also potentially be a factor in the inability to advance.Per the ifu/training manual, ''use of a stiff wire (for peripheral access only) can be used in cases with peripheral tortuosity (for example, supracore or lunderquist).This method may be utilized for straightening the vessel anatomy for access''.A stiffer wire could assist in straightening out the tortuous anatomy.As such, available information suggests that patient factors (calcification, tortuosity) and procedural factors (guidewire not stiff enough) may have contributed to the reported event.For the complaint of sheath liner punctured, an existing edwards' technical summary has been documented for root cause analysis on sheath shaft liner tears with normal liner expansion.The technical summary provides details of contributing factors for sheath shaft liner tears.The following patient and procedural factors were identified as contributing factors for sheath shaft liner tears: tortuous patient anatomy can create sub-optimal angles that can lead to nonaxial alignment in the advancement and retrieval of the delivery system.The delivery system or balloon catheter can potentially catch on to the tip or liner of the sheath and create tip damage or liner tears upon advancement.Tortuous anatomy was reported to be present in the patient's access vessels and was seen in returned patient imagery.The sheath also had a curvature to it, indicative of tortuosity.Calcification can damage the exposed portion of the sheath liner.Damage along the liner could lead to immediate cutting/tear or could weaken the liner.A weakened liner can tear during advancement or retrieval of the delivery system.Calcification was seen in the returned patient imagery.Incomplete deflation of the compatible balloon device prior to removal from the sheath can damage the liner.A balloon burst or tear could also make it difficult to deflate the balloon and would alter the balloon profile during removal.The force required to withdraw the balloon could then lead to tearing or weakening of the sheath liner.No incomplete deflation or balloon burst/tear was noted.The technical summary demonstrated that there were no deficiencies in the ifu/training manuals and also outlines the extensive manufacturing mitigations in place to detect a defect or nonconformance associated with sheath shaft liner tears.There are several 100% in-process inspections (visual) performed in manufacturing process and product verification testing (functional and visual) on a sampling plan basis performed prior to lot release.It should be noted that these mitigations (from manufacturing and the ifu/training manual), as identified in the technical summary, are still in place.As such, these inspections and testing support that it is unlikely that a manufacturing non-conformance contributed to the complaint.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the complaint event.No labeling or ifu inadequacies have been identified.Since no edwards defect was identified, no corrective or preventative action is required.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.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15170362
• MDR Text Key: 297311981
• Report Number: 2015691-2022-07167
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200258
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 9610ES16
• Device Catalogue Number: N/A
• Device Lot Number: 64291377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 07/11/2022; 09/09/2022
• Supplement Dates FDA Received: 09/08/2022; 09/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male