MAUDE Adverse Event Report: ANGIODYNAMICS ANGIOVAC; ANGIOVAC C20 WITH OBTURATOR

Model Number 25193

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

Patient Problem Death (1802)

Event Date 06/23/2020

Event Type  Death  

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The av circuit waste line was discarded by the user as there was no report of angiovac cannula device malfunction during the procedure.The customer's reported complaint description cannot be confirmed due to the nature of this patient adverse event; there were no reports of angiovac cannula device malfunction during the procedure.No sample was returned for evaluation.A device history record review of the packaging and purchased component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The root cause of the patient adverse event is potentially related to pulmonary embolism and subsequent cardiac complications as indicated by physician during post case review, "he [physician] felt as if at some point during the case a piece of material might have embolized and started the spiral [cardiac complications] but was not sure".As indicated in the event description, the physician was aware of the risks associated with performing an angiovac (av) procedure with a pfo present and the potential for material to embolize across it to the left heart and brain; however, using av c20 to debulk, based on the porous composition, seemed reasonable to the clinical team.Pulmonary embolism and death is identified as potential/anticipated procedural complication/adverse event of an angiovac procedure as indicated in the directions for use.Angiovac circuit micro-bubble leak: no product was returned for evaluation as the waste line t-connector was removed from the circuit at the beginning of the angiovac procedure (due to micro-bubbles observed).Potential root cause for the micro-bubble leak is bonding of the male fitting to the t-connector female.As this component was removed from the circuit at the beginning of the procedure, it is noted that this could not have contributed to the patient expiration that happened at the end of the angiovac procedure.Correction/corrective actions: no correction is required since there was no reported cannula device malfunction during the procedure, i.E.Device functioned as intended and did not directly contribute to patient expiration.Labeling review: the angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use (dfu, 14600506-01) 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.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.(b)(4).

Event Description

An angiodynamics clinical specialist reported an incident during an angiovac case.At the beginning of the case, a trans esophageal echocardiogram (tee) probe was placed,and the four chambers of the patient's heart were visualized.Porous material appeared to fill most of the right atrium (ra) and a patent foramen ovale (pfo) was visualized.The physician was aware of the risks associated with performing an angiovac (av) procedure with a pfo present and the potential for material to embolize across it to the left heart and brain; however, using av c20 to debulk ,based on the porous composition, seemed reasonable to the clinical team.The patient was prepped, and the right internal jugular vein was accessed.Right femoral vein (rfv) and left femoral vein (lfv) access were obtained with micropuncture and ultrasound guidance.The av circuit was then primed, run and confirmed to be free of air.The circuit was attached to the reinfusion cannula and the av and inserted into the rfv.Baseline and threshold flows were established in the inferior vena cava (ivc)/right atrium (ra) junction at roughly 3/lpm.The physician advanced the av towards the ra to engage the material over the wire, in the event the physician would later need to go into the superior vena cava (svc) and performed several sweeps.The tee began to show micro bubbles.The physician was asked to make sure the clear touy adapter was tight around wire and the red touy on the circuit was also finger tight, with no improvement.After investigating to see what else could cause the micro bubbles, connector on the t piece was found to be the issue.The circuit was turned off, the connector was removed and replaced by a 3/8 straight connector and micro bubbles were then removed from the circuit.At this time, the physician no longer wanted to work over wire; therefore, it was removed, and the pump was turned back on at roughly 3.0lpm.The material was engaged and began to debulk.At one-point, the av had a decent hold on the material and the physician waited 2 minutes for the material to become wedged into the funnel before oscillating rpm and pinching the tubing to help encourage the material to conform.After oscillating several times and pinching tubing, material was seen flowing through the circuit, to the bubble trap.At this point, the tee operator noted 30% of the material was removed.After several more sweeps, the av was pulled into the ivc/ra.Tee was then utilized to see if the material was still present and, according to the operator, imaging showed some improvement but 65-70% of the material was still present.Physician reengaged the material and attempted to gain a new angle to debulk more.After several passes, tee imaging quality appeared very cloudy as if bubbles were present in the ra.The perfusionist came off the pump and lights in the room turned on and revealed froth in filter.The circuit gave the impression that cavitation was on both the aspiration and return lines, so the reinfusion cannula was clamped, and the circuit was disconnected.Then, the angiovac was pulled into the ivc and a quick connect was plugged with the extra reinfusion adapter.Next, the circuit loop was reestablished to diminish the micro bubbles in the circuit so the procedure could be continued.At this time, the patient began to decompensate while the looped circuit was being recirculated, in preparation to reattach and resume procedure.A mega code was initiated, cpr, amiodarone, and 4 shocks (150j x2 and 200j x2) were administered; however, after several minutes of cpr, the physician decided to stop once they could not reestablish a pulse.Ultimately, the patient expired.Post procedure, information provided by the treating physician stated: "the autopsy and pathology came back on our patient which confirmed cancer in the ra and revealed metastatic emboli as the cause of death.So sorry we didn't have a better outcome, but it sounds like it was just a natural consequence of severe advanced cancer.".

• Brand Name: ANGIOVAC
• Type of Device: ANGIOVAC C20 WITH OBTURATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, ma ; 6587805
• MDR Report Key: 10276856
• MDR Text Key: 198904133
• Report Number: 1317056-2020-00114
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251930
• UDI-Public: H965251930
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2020

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 Expiration Date: 11/30/2021
• Device Model Number: 25193
• Device Catalogue Number: 25193
• Device Lot Number: 5550499
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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: 88 YR