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

Model Number 914ESJ

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/27/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.

Event Description

During device preparation, devices were prepared as instructed in the training manual and no defects were observed.During a transfemoral transcatheter aortic valve replacement (tavr) for the native aortic position, a 14 fr esheath was inserted via a puncture obtained on the left femoral artery.Prior to sheath insertion, six vascular closure devices were deployed.Sheath insertion had no problem.After valve deployment, the delivery system was removed.The physician inserted the introducer into the sheath and then removed.Resistance was felt at the sheath tip around the puncture site, however the sheath was completely removed.When the sheath tip was checked after removal, the sheath tip was torn about 5mm.The fragment was connected to the sheath, and it was confirmed by fluoroscopy and digital subtraction angiography (dsa) that there was no fragment left in the body.No adverse events occurred.The cause was discussed with the physician, but there was no significant calcification on the preoperative ct, and no clear cause was identified.Although interference with the perclose knots was considered, there was no trouble observed at the puncture site after sheath removal.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings.Sections b4, g3, g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been updated.The device was not returned to edwards lifesciences for evaluation.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 event is not required at this time.The complaints for withdraw sheath from access site - difficulty removing sheath and sheath distal tip torn were confirmed per returned procedural imagery.However, no manufacturing nonconformance was identified during evaluation.A dhr and lot history were unable to be performed as no lot information was returned.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.Per the complaint description, -sheath insertion had no problem.After valve deployment, delivery system was removed.Inserted the introducer into the sheath and remove them, resistance was felt at the sheath tip around the puncture site, however the sheath was completely removed.When the sheath tip was checked after removal, the sheath tip torn about 5mm was observed.The fragment was connected to the sheath, and it was confirmed by fluoroscopy and digital subtraction angiography (dsa) that there was no fragment left in the body-.Per evaluation of the procedural imagery, the sheath distal tip was observed to be torn radially.The failure mode is characteristic of sheath tip tear events as described in pra0964.While a definitive 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.Additionally, complaint information states that -the access vessel calcification was mild.The access vessel tortuosity was moderate.- returned patient imagery also showed tortuosity.Tortuosity can lead to non-coaxial alignment between the crimped valve and the sheath, which may lead to an increased potential for the valve struts to catch onto the sheath distal tip or for non-coaxial alignment during withdrawal of the delivery system.Once the distal tip tore, it likely caused resistance during withdrawal at the puncture site, causing the difficulty in withdrawing.As such, the failure mode may be related to improper expansion of the sheath tip during thv advancement and/or patient factors (tortuosity) may have contributed to distal tip tearing.However, a definitive root cause was unable to be determined at this time.Available information suggests that the difficulty withdrawing likely may have occurred due to procedural factors (distal tip tear).The complaint for withdraw sheath from access site - difficulty removing sheath was confirmed.However, no manufacturing nonconformance was identified during evaluation.Available information suggests that procedural factors (distal tip tear) may have contributed to the complaint event.No ifu/training manual deficiencies were identified.No corrective/preventative action nor pra escalation are required at this time.The complaint for sheath distal tip torn was confirmed.However, no manufacturing nonconformance was identified during evaluation.The failure mode is likely related to improper expansion of the sheath tip during thv advancement and/or patient factors (tortuosity) may have contributed to the complaint event.However, a definitive root cause was unable to be determined.A product risk assessment was previously initiated per management discretion to document investigation and assess associated risks for the issue.In addition, a capa was previously initiated to capture further investigation and any possible corrective or preventative action activities.

• 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: 15084133
• MDR Text Key: 304333803
• Report Number: 2015691-2022-06951
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 914ESJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 96 YR
• Patient Sex: Female