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

Model Number 916ESPJ

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 07/20/2023

Event Type  Injury  

Event Description

During a tavr procedure using a 29mm sapien 3 resilia valve via transfemoral approach.When the 29mm commander delivery system passed through a 16fr esheath+, significant resistance was experienced.The operator had difficulty in passing the delivery through the partially expandable part of the sheath.The delivery system was pushed by force and eventually could be passed through the sheath.A 29 mm sapien 3 ultra resilia valve was deployed uneventfully.At the time of access closure, dissection was noted around the puncture site and surgical repair was conducted.The patient left the operating room and was transferred to icu without problems.When the sheath was checked after use, the distal tip was observed to be torn.The patient's outcome was reported as "recovered".The implanter was unclear whether the torn distal tip was involved in the dissection.The device will be returned for evaluation.Per report, the access was obtained from the right fa via surgical cutdown.The vessel was not pre-dilated, and no damage was observed on the delivery system.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

Correction to h6; type of investigation, investigation findings, investigation conclusion.Update to d9 and h3.The 16 fr esheath plus was returned to edwards lifesciences for evaluation and confirmed the reported event.Imagery was provided and showed that the distal tip was torn radially along the distal edge of the liner, tortuosity and calcification were present in the patients access vessel.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed complaints relating to the complaint code.However, lot history review did not provide any indication that a manufacturing non-conformance would have contributed to the complaint event.The esheath+ ifu, commander delivery system ifu, and device preparation manual instructions and procedural training manual for use (ifu) were reviewed.Based on the review, no ifu/training deficiencies were identified.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 reported event of sheath distal tip torn was confirmed per evaluation of the returned device.However, no manufacturing nonconformance was identified during evaluation.Review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.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, no abnormalities were noted during device unpacking or preparation.As reported, "during transfemoral transcatheter aortic valve replacement (tavr) for native aortic position, the access was obtained from the right fa via surgical cutdown.When a 29mm commander delivery system passed through a 16fr esheath+, significant resistance was experienced.The operator had difficulty in passing the delivery through the partially expandable part of the sheath.The delivery system was pushed by force and eventually could be passed through the sheath.When the sheath was checked after use, the distal tip damage was observed." the failure mode is characteristic of sheath tip tear events as described in a previous risk assessment.While a conclusive root cause was unable to be determined, previous investigation indicated that the tear is attributed to improper tip expansion, resulting in interference between the valve and sheath tip.As such, it is possible that improper tip expansion contributed to the experienced delivery system advancement resistance at the sheath distal tip and the distal tip tear.Per evaluation of the returned device, the sheath shaft was slightly curved, suggesting the presence of tortuosity.Additionally, the 3mensio imagery was also provided and shows the presence of access vessel tortuosity and calcification.Calcification can weaken the sheath distal tip.Tortuosity and calcification can lead to non-coaxial alignment between the crimped valve and the sheath, which may lead to the valve struts to catch onto the sheath distal tip and tearing the tip.The failure mode may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (tortuosity, calcification) may have contributed to the complaint events.The reported event for resistance and difficult advancing was confirmed per evaluation of the returned device.An existing technical summary captures the root cause analysis for complaints evaluated for resistance with delivery system and valve frame damage as a result from increased push force.The root causes identified in technical summary were reviewed and the following were identified as applicable to this event: tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.Kinks or curvature along the sheath shaft can be indicative of the presence of vessel tortuosity.Per evaluation of the returned imagery, tortuosity was present in the patient's access vessels.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Similar to tortuosity, calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.Scratches observed on the sheath shaft can be indicative of the presence of calcified nodules within the access vessel.Per evaluation of the returned imagery, calcification was present in the patient's access vessels.The presence of the above factors can create a challenging pathway during delivery system advancement, leading to resistance.More than one of these factors can compound to further exacerbate the patient/procedural conditions and increase the likelihood of encountering resistance during delivery system advancement through the sheath.The technical summary also outlines the extensive manufacturing mitigations in place to detect a defect or non conformance associated with this issue.There are several 100% in process inspections (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, assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.In this case, available information suggests that patient factors (tortuosity, calcification) may have contributed to the reported event.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 ew, 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.The minimum required vessel diameter for an (16 fr sheath is 6.0 mm).In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that the mechanisms of the tavr procedure described above, or patient factors may have caused or contributed to the 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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• 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: 17542296
• MDR Text Key: 321147192
• Report Number: 2015691-2023-15232
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00690103217377
• UDI-Public: (01)00690103217377(17)250124(10)64847522
• 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
• Report Date: 10/26/2023

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 Model Number: 916ESPJ
• Device Lot Number: 64847522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 10/24/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2023
• 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: 78 YR
• Patient Sex: Female