MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / ANGIOVAC; CATHETER, CANNULA & TUBING, CARDIOPULMONARY

Model Number 25194

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Cardiac Arrest (1762)

Event Date 05/22/2023

Event Type  Death  

Manufacturer Narrative

The disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

A clinical specialist reported an that during a procedure and post use of an angiovac c180 with obturator, the patient expired.There was no device malfunction as the angiovac device portion of the procedure had been successful.76/f presented with shortness of breath for several months.Found to have clot completely occluding the right pulmonary artery and a large clot in transit in the right atrium.Dr.(b)(6) reached out to us for removal of right atrial clot in transit and possible removal of pulmonary embolism.Stated he wanted to use angiovac for pe due to patient's poor renal function and inability to tolerate contrast.I informed dr.(b)(6) that pe portion of case would be an off-label use of the device and he wished to proceed anyway.Patient was taken to cath lab at (b)(6) hospital on (b)(6)2023.Plan was for left formal vein reinfusion using 17f cannula, right ij access with 26f sheath for aspiration with the angiovac c180 cannula.The right femoral vein and artery were accessed for ecmo cannulation, which dr.(b)(6) believed to be possibly needed during the procedure due to the patient's poor condition.All access was gained without issue after act confirmed >300.Patient was restless and moving too much, so dr.(b)(6) ordered a dose of fentanyl and versed be given.After dose was given, patient's breathing became labored.Dr.(b)(6) requested to have respiratory therapy come and placed patient on a bipap to assist breathing.At this time dr.(b)(6) stated that we needed to move more quickly.Reinfusion cannula was attached to angiovac circuit, angiovac cannula was then advanced through the sheath in the right ij and into the svc.At this point, we commenced flow at 2 liters per minute.We slowly ramped up to 4 liters per minute and advanced the angiovac towards the tumbling clot in the right atrium.Flow stopped and a large amount of material was noticed slowly moving in the tubing towards the bubble trap.After approximately 20 seconds, the clot reached the bubble trap and flow resumed at 4lpm.Using echocardiography, it was confirmed that the entire right atrium clot in transit was removed.Angiovac circuit was clamped off and the angiovac cannula was removed by dr.(b)(6).Respiratory therapy arrived around this time and stated they couldn't place patient on bipap due to her head being covered by sterile drape and having a large cannula coming out of her neck.The plan for the next portion of the procedure was for the physician to place a stiff wire in the pulmonary artery, then place the angiovac in the pulmonary artery and attempt to suction out the clot in the right pa.However, patient's breathing was deteriorating and they were not able to consistently gain an oxygen saturation reading.It was bouncing between 99% and as low as 60%, so dr.(b)(6) decided to place the patient on ecmo.Using the venous and arterial sheaths that were already in place in the right groin, dr.Upsized to venous and arterial cannulas for initiation of ecmo.These were placed without delay and ecmo was initiated at 3-4 liters per minute.Patient's heart rate went from 100 bpm to 60 bpm after initiation.The pulse oximetry reading was still having difficulty picking up and was bouncing between 30% and 100%.Per the perfusionist, (b)(6), this is not uncommon due to the laminar flow of the ecmo circuit while the pulse oximeter reads pulsatile flow.He did not feel this was unusual.Dr.(b)(6) then began accessing the left femoral artery for blood pressure monitoring (the previous arterial line had been removed from the right groin during ecmo cannulation).Blood pressure reading after insertion was 250/250mmhg.This prompted troubleshooting and several attempts to re-zero the line.Patient's heart rate began to decrease to 30 bpm during this troubleshooting.Dr.(b)(6) called for anesthesia to come intubate the patient.He then ordered a dose of atropine be given and he started to work on another arterial access for blood pressure monitoring because he did not believe the 250/250mmhg reading being given by the left femoral artery.Once placed, the new arterial line showed a pressure of 200/200mmhg.Anesthesia arrived and intubated the patient.They also placed a transesophageal echocardiogram probe and it showed no movement at the heart.Heart rate on the ecg reading was continuing to drop, now reading 10 bpm of a wide complex ecg tracing.Dr.(b)(6) repeatedly stated he did not know why the ecmo wasn't helping the patient's heart.After several minutes passed with no improvements in the patient's condition, he ordered the perfusionist to shut off the ecmo, as the patient was deceased.As the sales rep, (b)(6), and i, began to assess the clot we had removed in the bubble trap, dr.(b)(6) came over to look.He saw the removed clot and stated that he felt the angiovac portion of the procedure had been successful.He then stated that he thought the patient may have developed a "brain bleed" from the heparin she received and this would have explained the profound hypertension after the initiation of ecmo.

Manufacturer Narrative

The customer's reported complaint description cannot be confirmed due to the nature of this patient serious adverse event (cardiac complications); there were no reports of angiovac device malfunction during the procedure, therefore, no sample was returned for evaluation.Cardiac complications are potential anticipated procedural complication of an angiovac procedure; this is cautioned in the dfu.The patient expiration is potentially are a result of the patient's co-morbidity.In lieu of a reported lot number, a ship history report (shr) was generated for item number (h965251940) in order to ascertain the last three lots shipped to the reporting customer in the six (6) months prior to the procedure date.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use is provided with this device and contains the following statements: warnings: selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians' sole responsibility.The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique.The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.As with all medical devices, this device and ancillary equipment are to be used by trained physicians only.Specifically, this device is to be used only by medical personnel experienced with initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (seldinger) vascular access techniques.Adverse events: this device, as do all extracorporeal blood vessel devices, has possible side effects, which include but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques.These may occur if the instructions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: death, arrhythmias, pulmonary embolism.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17071834
• MDR Text Key: 316625457
• Report Number: 1317056-2023-00070
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251940
• UDI-Public: H965251940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142593
• 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: 07/17/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 25194
• Device Catalogue Number: 25194
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/17/2023
• 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 Outcome(s): Death
• Patient Age: 76 YR
• Patient Sex: Female