MAUDE Adverse Event Report: EDWARDS LIFESCIENCES FEM-FLEX II FEMORAL ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	FEMII020A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: the patient died while using a medical product, but there was no suspected association between the death and the use of the product.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, an appropriate investigation will be performed.
Event or Problem Description
It was reported that the femii020a cannula snapped/broke after three days after the initial placement.Additional information received: the patient was about to be prepped and draped however we noticed significant bleeding from the right ij cannula, we noticed that the cannula was cracked as a result we quickly stopped the ecmo and clamped that cannula and this was followed by switching the configuration of vv ecmo to a fem fem vv ecmo and removed the right ij femflex cannula.The pressure was held and no hematoma developed.The cannula was removed and replaced with a 32 f mc3 cannula placed in left ij.On pod #4, the patient expired.The patient's death was not related to the catheter.
Additional Manufacturer Narrative
H10: additional manufacturer narrative: updated sections: b5, b7, and h6 (health effect - impact code, and type of investigation).
Event or Problem Description
It was reported that the femii020a cannula snapped/broke after three days of the initial placement.Per the medical records, the patient presented with covid pneumonia with ards.Medical management was exhausted; therefore, the patient was placed on vv ecmo, with right ij femflex cannula, and right and left femoral venous cannulae.Three days later, the patient was brought to the or to change the configuration of the vv ecmo to subclavian access in order to make him more mobile and prevent any mixing.The patient was about to be prepped and draped however significant bleeding was noticed from the right ij femflex cannula, it was noticed that the cannula was cracked.As a result, the ecmo was quickly stopped and the cannula was clamped.This was followed by switching the configuration of vv ecmo to a fem fem vv ecmo and removal of the right ij femflex cannula.The pressure was held and no hematoma developed.The removed cannula was replaced with a 32 f mc3 cannula placed in the left subclavian vein.This was accompanied by air embolism shunting to the left heart via pfo noted.The air in the heart was resolved quickly.At this point, it was able to change the configuration and remove both femoral venous cannulae.Neurosurgery and neurology were consulted due to the assumption that air traveled to the brain; however, head ct showed no evidence of cerebral edema.Overnight, the patient developed a-fib rvr resulting in hypotension and requiring five cardioversions.On pod #5, a code blue was called due to bradycardia and asystole.Despite all efforts, the patient expired soon after.Per medical opinion, the patient's death was not related to the catheter.Product evaluation summary: customer report of broken cannula was confirmed.As received, the proximal end of the cannula, including the barbed connector, was observed to be cut-off at the non-wire reinforced section and was not returned with the device.Cross surfaces of broken cannula appeared smooth and even.Cannula was partially broken at the wire-reinforced section next to the suture ring, approximately 1.8" from the proximal end.Multiple wire-reinforced sections of the cannula body were observed to be kinked.No other visual damage, contamination, or other abnormalities were found.
Additional Manufacturer Narrative
Based on the provided information, the device was used for ecmo and for longer than 6 hours, which is contraindicated per the ifu (ifu 10008642002, rev a).The most likely cause of the damaged cannula is the contraindicated use.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

• Brand Name: FEM-FLEX II FEMORAL ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: gail warner ; 1 edwards way; mailstop ant 6.1; irvine, CA 92614 ; 9492504096
• MDR Report Key: 12541219
• Report Number: 2015691-2021-05399
• Device Sequence Number: 13042136
• Product Code: DWF
• UDI-Device Identifier: 00690103031287
• UDI-Public: (01)00690103031287(17)231125(11)2011252163476849
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2023
• Device Model Number: FEMII020A
• Was Device Available for Evaluation?: Yes
• 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: 09/03/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 12/10/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/08/2021; 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2020
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Other
• Patient Age: 29 YR
• Patient Sex: Male