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

Catalog Number UNKNOWN

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

Patient Problems Pulmonary Embolism (1498); Death (1802)

Event Date 09/12/2019

Event Type  Death  

Manufacturer Narrative

The customer reported a serious adverse event (sae), i.E.Patient death, with the use of the angiovac device but there was no reported malfunction of the cannula or circuit during the procedure.No sample was returned for evaluation as there was no device malfunction.The root cause of the sae is likely a result of the patient's comorbidity (i.E.Recurrent pe).Post event, the treating physician stated the patient had succumbed to his pe and that the angiovac was in no way at fault for the decline/expiration of the patient.No device identifying information was provided by the complainant other then that the device used was an angiovac system.As there was no device identifying information, a device history record review could not be performed.The recent angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was identified.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, pulmonary embolism.Complaint # (b)(4).

Event Description

As reported: the case was added emergently as the patient had a recurrent pe.Upon arrival to the lab, the inari portion of the case had been completed in the pa and the patient was stable.58 y/o bm, 6'7", 355#.The angiovac cannula and circuit were primed/prepped using sterile technique and in accordance with the ifu.Access: rij for 26f gds and lfv for the 18f arterial reinfusion cannula.The angiovac was inserted through the gds over an amplatz ss 260cm wire, balloon inflated per ifu and petal expansion confirmed via fluoro.Flow initiated and optimized at 3lpm.There was an ivc filter present that dr.(b)(6) placed one week ago.There was a small amount of thrombus on top of the filter which extended down the ivc to the confluence.The avac engaged the material at the top of the filter and a small amount of dark, fresh appearing thrombus was captured.The angiovac was placed just inferior to the caval atrial junction and flows remained at 3lpm while a retrieval sheath was inserted and the ivc filter snared and removed without incident.The avac cannula was then advanced to the thrombus in the ivc and flow dropped to zero.Perfusion oscillated the rpm on the pump for approximately 3 minutes in an attempt to bring the material through the cannula and into the filter, which was unsuccessful.An mpa 1 cannula was inserted through the rfv access that was used for the inari device.Via fluoro, it was confirmed that there was material on the distal end of the avac cannula.The mpa1 was then inserted through the tuohy and contrast media injected into the cannula to confirm that the material was engaged into the body of the cannula.Once that was confirmed, the balloon was deflated and the cannula was removed through the gds while on suction.Once outside the body, there was no material in the cannula, but there was no bleedback from the gds.The physician placed a wire through the gds and removed it.The sheath was flushed revealing a 2cm x 4cm clot that was fibrotic.Ij access was re-established with the 26f gds, cannula reinserted, and flows restored.While engaging the material again, the patient's o2 sat dropped into the 50s and systolic pressure also dropped into the 50s.The angiovac cannula remained in the ivc, never entering the ra, with flows decreased to 2lpm while dr.(b)(6) reinserted the inari device through the rfv access to do more work within the pa.The patients pressure and sats returned to normal while on neosynephrine, epinephrine and also was receiving blood and blood products due to the loss of blood while using the inari device.Ultimately, the patient coded on the table, cpr was initiated, but the patient did not recover from his pe (anesthesia stated that he was no longer oxygenating and there was confirmation of a large volume of material in the l and r pa's) and expired on the table.The treating physician stated, post event, that the patient succumbed to his pe and that the angiovac was in no way at fault for the decline/expiration of the patient.The device used during the procedure was discarded at the hospital.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMONARY BYPASS
• 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: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 9130834
• MDR Text Key: 160452238
• Report Number: 1317056-2019-00121
• Device Sequence Number: 1
• Product Code: DWF
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/27/2019

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 09/27/2019
• 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: 58 YR
• Patient Weight: 161