MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSFEMORAL BALLOON CATHETER; BALLOON AORTIC VALVULOPLASTY

Model Number 9350BC25

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 09/16/2022

Event Type  Injury  

Event Description

As reported, it was a case of a 29mm sapien 3 valve, by transfemoral approach.During the valvuloplasty, the bav balloon ruptured and was stuck in the introducer at the time of withdrawal.Another kit was opened to complete the procedure.This incident resulted in a postoperative stroke.

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information.The following sections of this report have been updated: corrected h.6 component codes and investigation conclusions and investigation findings.Added new information to h.6 type of investigation.The device was returned to edwards lifesciences for evaluation and the following was observed.Bav has several kinks shaft due to packing.Balloon burst was confirmed.Longitudinal burst.No missing balloon material.Imagery was not provided for review.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.Per the instructions for use (ifu), permanent or transient neurological events such as transient ischemic attack (tia) and stroke are known potential adverse events associated with the thv procedure and the use of the edwards thv devices.According to the literature review, and as documented in a clinical technical summary written by ew, stroke is recognized in the literature as a well-known complication in a small number of patients undergoing thv.Risk factors correlating with several patient co-morbidities have been identified.Although in many cases the root cause of the event is unable to be determined, strokes during thv are undoubtedly multifactorial, the dominant etiology likely being intra-procedure embolic events.A transcranial doppler study during thv demonstrated that most procedural embolic events occurred during balloon valvuloplasty, manipulation of catheters across the aortic valve, and valve implantation.An analysis in patients undergoing valve surgery revealed four baseline characteristics and two procedural events that were associated with early post-procedure stroke: female sex, ef < 30%, diabetes, age older than 70 years, bypass procedure time> 120 min, and calcification of the ascending aorta.Predictors of late stroke have included female sex, age older than 75 years, atrial fibrillation, and a history of or current smoking.There were no significant differences in the frequency of late strokes between thv and avr patients.After thv, there appears to be a more considerable proportion of early strokes occurring < 24 h post-procedure, but thv patients with multiple co-morbidities are probably at higher risk of both early and late strokes.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Investigation results suggest/indicate that patient conditions could have 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.For index procedure events: 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.The complains were confirmed upon visual inspection of the returned device.However, no manufacturing non-conformances were identified during the evaluation.A review of the dhr, complaint history, and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.In this case, ''during the valvuloplasty, rupture of the balloon occurred'' patient anatomy was not provided.However based on review of the complaint history, calcification can compromise the structure of the balloon leading to the burst noted.Additionally, the withdrawal of the balloon with the altered profile may have led to the withdrawal difficulties.However, due to limited information a definitive root cause was unable to be determined at this time, however patient factors (calcification) or procedural factors (withdrawal of burst balloon) may have contributed to the reported event.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 ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: EDWARDS TRANSFEMORAL BALLOON CATHETER
• Type of Device: BALLOON AORTIC VALVULOPLASTY
• 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
• MDR Report Key: 15591343
• MDR Text Key: 301631617
• Report Number: 2015691-2022-08538
• Device Sequence Number: 1
• Product Code: OZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140241
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2024
• Device Model Number: 9350BC25
• Device Catalogue Number: 9350BC25A
• Device Lot Number: 64348698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2022
• 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: 74 YR