MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DILATOR KIT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	9100DKSA
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field clinical specialist (fcs), during a transfemoral transcatheter aortic valve replacement (tavr) procedure of a 23mm sapien 3 ultra valve, it was noted there was anticipated vascular disease of the access vessels.The vessel was dilated with a 7mm shockwave balloon and the 16fr dilator that came with the esheath+ kit.An additional angioplasty was performed on the vessel with an 8mm shockwave balloon.An edwards dilator kit was then opened and the esheath+ was withdrawn from the patient and exchanged for a 18fr dilator.The dilator was withdrawn, and a new esheath+ was inserted and advanced in the patient.After the dilator was withdrawn, it was inspected and observed to have been gouged with pieces shaving off.One piece was noted to have fallen off; however, there were no dilator pieces found in the vessel.
Additional Manufacturer Narrative
The investigation is ongoing.Pending device return.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction based on further assessment of the reported event.The following section of this report have been corrected: h6 (device code).The investigation is still ongoing.
Additional Manufacturer Narrative
A supplemental mdr is being submitted for correction and includes additional information based on device evaluation.The following sections of this report have been corrected/updated: d9 (device availability), h3 (device evaluated by manufacturer), h6 (component code, type of investigation, investigation findings, investigation conclusions) and h10 (provide narrative/data).The device was returned to edwards lifesciences for evaluation.Visual inspection of the returned device revealed shaved material matching the imagery that was provided.There were two scratch marks noted on the dilator.Onset of the scratches were located approximately 2 inches from the distal end and 1.75 inches in length.Imagery provided was also reviewed.Undersized vessels, calcification and tortuosity were observed in patient's access vessels.In addition, dilator damage was observed on the returned procedural imagery.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 also performed and revealed no other events relating to the reported event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the dilator usage.Per the ifu, the product is contraindicated for tortuous or calcified vessels that would prevent safe entry of a dilator.Based on the review of the ifu/training manuals, no 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 event for damaged dilator was confirmed through evaluation of the returned device and returned procedural imagery.However, no manufacturing non-conformance was identified that may have contributed to the event.A review of the dhr, lot history, and complaint history showed no indication a manufacturing non-conformance contributed to the event.In addition, no ifu/training manual deficiencies were identified.As reported, "after the dilator was withdrawn, it was inspected and observed to have been gouged with pieces shaving off.One piece was noted to have fallen off; however, there were no dilator pieces found in the vessel." returned patient imagery showed undersized vessels and calcification in the patient's access vessels.Per the ifu, "this product is contraindicated for tortuous or calcified vessels that would prevent safe entry of a dilator." calcification and undersized vessels can reduce the vessel lumen diameter and create added friction on the dilator.The dilator likely became damaged through contact with sharp calcified nodules.In this case, available information suggests that patient factors (calcification and undersized vessels) may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No product risk assessment (pra) nor corrective or preventative actions are required.

• Brand Name: DILATOR KIT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 15348886
• Report Number: 2015691-2022-07666
• Device Sequence Number: 5467325
• Product Code: DRE
• UDI-Device Identifier: 00690103192391
• UDI-Public: (01)00690103192391(17)240217(10)63702078
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K093554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2024
• Device Model Number: 9100DKSA
• Device Catalogue Number: 9100DKSA
• Device Lot Number: 63702078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2022
• Supplement Date Received by Manufacturer: 08/31/2022; 11/15/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/24/2022; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female