MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

Model Number 20000GS

Device Problem Difficult to Insert (1316)

Patient Problem Perforation of Vessels (2135)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position.During procedure a bleeding event occurred.Physician had some issues with the femoral access while introducing the dilators in the vein, but as per medical opinion it was normal in old patients.The guide sheath (gs) was inserted until the inferior vena cava when it was noticed that physicians could not move the flush port to 12 o'clock.At the same time patient started to decompensate blood pressure and it became very low.At this moment physician considered it might be due to the puncture site, introduced some contrast using a second access and confirmed that the vein was broken.The device was left covered by sterile drape as physician though it could be possible to continue with the procedure after the vascular surgeons repaired the vein.However, it was ruptured due to gs introduction from femoral to iliac vein and it was needed to perform surgery in the cath lab.Surgeons informed the gs could not come out as it was maintaining the pressure in the vein and avoiding more bleeding.At this point edwards personnel present left the lab.Surgery ended up well with no other damage to the patient, who was recovering and stable.As per the cs, the patient had been treated with radiotherapy for ca in the area so it could have been the reason of the easier rupture of the vein.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Adverse event outcome: other serious- vein rupture.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.Device not returned.

Manufacturer Narrative

According to the instructions for use (ifu), vascular complications, including hematoma and bleeding are potential adverse events associated with transfemoral transcatheter valve repair.Patients who present for transcatheter valve repair have severe mitral and/or tricuspid regurgitation with heart failure, are typically high risk, and are prone to bleeding secondary to underlying conditions and frequent use of chronic anticoagulation.As these procedures require the placement of large bore devices, the placement of sheaths and dilators in these vessels may result in damage to the venous access site, vascular damage, or perforation.Vascular access site related bleeding, hematoma, and other complications are typically related to procedural technique during the insertion or removal of the sheath and/or dilators in the context of anticoagulation regimens, and may require, transfusion, surgical repair, or other interventions.These events are foreseeable and may be procedural related and/or patient factor related (a combination of sheath size, vessel size and tortuosity, vessel frailty, and calcifications).The device training manuals instructs the operator to consider all procedural and anatomical factors.Physicians are extensively trained by edwards before they are qualified to use the device system.Training includes patient screening, device preparation, approach, deployment, imaging, procedure specific training manuals and proctored procedures.Operators are also instructed to pre dilate the vessel with dilators, as needed and use fluoroscopy in conjunction with echocardiography for optimal visualization during device positioning and deployment.Cautions include the assessment and maintenance of the patient anticoagulation status.There was no allegation or indication a device malfunction contributed to this adverse event; the device was not returned to confirm any device malfunction.No pre-procedural (baseline) or procedural echocardiography or fluoroscopic imaging was returned for review to evaluate conditions of patient vasculature.Investigation results indicate that the root cause is likely influenced by patient related conditions.As reported by the clinical specialist, the patient history is significant for radiotherapy treatment local to the vascular rupture site.Radiation treatment for cancer is known to negatively affect surrounding, healthy tissue.The type of damage occurs at a cellular level and is dose, time, and patient dependent.Fibrosis, inflammation, and poor wound healing are known side effects of radiation treatment.As reported by the edwards on-site clinical specialist, the physician experienced difficulty when dilating the femoral vein and mentioned that the guide sheath was unable to be rotated once it had been inserted over the guidewire.This suggests that excessive force may have been needed to dilate the vein and to insert the guide sheath, which likely contributed to the vasculature rupture.The complaint for difficult to insert device into patient resulting in tissue damage was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the investigation.Investigation results suggest that the root cause is not likely to be related to the device.Available information indicates that patient conditions (local radiotherapy treatment for cancer, difficulty dilating femoral vein) contributed to the reported event, as well as the procedural handling of the device (difficulty inserting resulting in potential excess force).

Manufacturer Narrative

According to the instructions for use (ifu), vascular complications, including hematoma and bleeding are potential adverse events associated with transfemoral transcatheter valve repair.Patients who present for transcatheter valve repair have severe mitral and/or tricuspid regurgitation with heart failure, are typically high risk, and are prone to bleeding secondary to underlying conditions and frequent use of chronic anticoagulation.As these procedures require the placement of large bore devices, the placement of sheaths and dilators in these vessels may result in damage to the venous access site, vascular damage, or perforation.Vascular access site related bleeding, hematoma, and other complications are typically related to procedural technique during the insertion or removal of the sheath and or dilators in the context of anticoagulation regimens, and may require, transfusion, surgical repair, or other interventions.These events are foreseeable and may be procedural related and or patient factor related (a combination of sheath size, vessel size and tortuosity, vessel frailty, and calcifications).The device training manuals instructs the operator to consider all procedural and anatomical factors.Physicians are extensively trained by edwards before they are qualified to use the device system.Training includes patient screening, device preparation, approach, deployment, imaging, procedure specific training manuals and proctored procedures.Operators are also instructed to pre dilate the vessel with dilators, as needed and use fluoroscopy in conjunction with echocardiography for optimal visualization during device positioning and deployment.Cautions include the assessment and maintenance of the patient anticoagulation status.There was no allegation or indication a device malfunction contributed to this adverse event; the device was not returned to confirm any device malfunction.No pre-procedural (baseline) or procedural echocardiography or fluoroscopic imaging was returned for review to evaluate conditions of patient vasculature.Investigation results indicate that the root cause is likely influenced by patient related conditions.As reported by the clinical specialist, the patient history is significant for radiotherapy treatment local to the vascular rupture site radiation treatment for cancer is known to negatively affect surrounding, healthy tissue.The type of damage occurs at a cellular level and is dose, time, and patient dependent.Fibrosis, inflammation, and poor wound healing are known side effects of radiation treatment.As reported by the edwards on-site clinical specialist, the physician experienced difficulty when dilating the femoral vein and mentioned that the guide sheath was unable to be rotated once it had been inserted over the guidewire.This suggests that excessive force may have been needed to dilate the vein and to insert the guide sheath, which likely contributed to the vasculature rupture.However, due to the lack of device return and insufficient patient history, a definite root cause is unable to be determined.The complaint for difficult to insert device into patient resulting in tissue damage was confirmed with other empirical evidence.No manufacturing non-conformities were identified from the investigation.Investigation results suggest that the root cause is not likely to be related to the device.Available information indicates that patient conditions (local radiotherapy treatment for cancer, difficulty dilating femoral vein) contributed to the reported event, as well as the procedural handling of the device (difficulty inserting resulting in potential excess force).

• Brand Name: EDWARDS PASCAL PRECISION
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 16446238
• MDR Text Key: 310280032
• Report Number: 2015691-2023-11123
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)240111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2023

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 Expiration Date: 01/11/2024
• Device Model Number: 20000GS
• Device Lot Number: 64820622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 04/06/2023; 05/04/2023
• Supplement Dates FDA Received: 04/07/2023; 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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): Other