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

Catalog Number H965251860

Device Problems Material Rupture (1546); Aspiration Issue (2883)

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

Event Date 06/02/2018

Event Type  Death  

Manufacturer Narrative

No sample will be returned for evaluation, however as the angiovac is a purchased device for angiodynamics, the manufacturer, duke empirical, will be made aware of the event and requested to provide a review of the device history records for the components associated with the reported lot number.A supplemental medwatch will be submitted upon completion of the investigation.(b)(4).

Event Description

Description: a (b)(6) morbidly obese male with history of mva spinal trauma and repair on (b)(6) 2018.A preventative conical ivc filter placed on date of trauma.The ivc filter was tilted with the hook extending into the right renal vein.Ct exam performed approximately two weeks after placement revealed large thrombus from bilateral femorals extending cephalically to the renal veins.The patient was brought into the ir suite and placed supine.After prep and drape of the bilateral internal jugular region.Micropuncture access performed on both left and right internal jugulars.Twelve-thousand ("12,0000") units of heparin was given.Serial dilatation performed in the left internal jugular.An 18fr edwards fem flex arterial return cannula was placed and secured with suture in the left internal jugular vein.The return cannula was connected to the primed circuit.Serial dilatation of the right internal jugular performed.A 26fr gore dryseal was placed in the right internal jugular extending to the ra/ivc junction.Act performed resulting in a 268 second result.Additional 5,000 units of heparin given.A 260 cm amplatz wire was placed in the gore dryseal and extended to the left femoral vein.The angiovac was placed over the wire into the ivc at the level of the hepatic vein.The wire was secured by tightening the touhy adaptor port.The angiovac balloon was inflated to 1.5 atms.Flow was optimized at 1.5 liters per minute.The angiovac was advanced to the level of the ivc filter.Flow rates immediately dropped to zero.Approximately 2 minutes of zero flow rates with 3300 rpms, the angiovac was removed through the gore dryseal on suction.Large amount of thrombus removed from the cannula tip.Act performed approximately 10 minutes after heparin bolus revealed act below 260.The assisting ct surgeon ordered antithrombin iii given.Act re-drawn after approximately 5 minutes after bolus.Act >360 achieved.Angiovac was re-prepped and placed into the gore dryseal to the renal vein level.The physician elected to re-inflate the angiovac balloon to 2 atms.Flow rates optimized at 1.5 liters per minute.Angiovac advanced through the ivc filter.Flow rates dropped to zero.Approximately 2 minutes with no flow, the angiovac was removed on suction.Large amount of thrombus removed from the cannula tip.The angiovac was re-prepped and placed in the gore dryseal through the ivc filter.Flow rates optimized at 1.5 liters per minute.Angiovac advanced to the level of the left iliac.Flow rates dropped to zero.Angiovac removed on suction.The angiovac was re-prepped.The angiovac was unable to be passed through the gore dryseal.The physician stated the balloon appeared ruptured, while passing through the ivc filter.Another angiovac cannula was prepped and placed through the gore dryseal through the ivc filter.The physician elected to overinflate the angiovac balloon to 3 atms after discussing issues with over-inflation of the angiovac balloon.Flow rates of 1.5 liters obtained.Angiovac advanced to the left iliac vein.Flow rates dropped to zero.After approximately two minutes, a large column of thrombus was seen in the circuit.The angiovac was retracted through the ivc filter above the renal veins.Flow could not be re-established due to the large amount of thrombus in the circuit.The thrombus was worked through the circuit to the bubble trap filter with perfusion increasing rpms on the centrifugal pump and circuit compression techniques.The thrombus was cleared from the circuit and flow rates above the ivc filter was re-established at 2 liters per minute.The bubble trap filter was exchanged.The physician elected to access the left femoral vein above the popliteal with a 7fr sheath.The argon cleaner wire was placed through the 7fr sheath.The cleaner wire was activated throughout the left femoral and left iliac.The bubble trap reached capacity.Circuit clamped and bubble trap exchanged.Angiovac flow re-established to 1.5 liters above the ivc filter.Venogram performed revealed possible may-thurner compression in the left iliac vein.Thrombus was resolved from left femoral through ivc filter.Physician stated he will perform ivus and stent the left iliac at angiovac procedure conclusion.Physician elected to access the right femoral vein with a 7fr sheath.The assisting ct surgeon instructed her perfusion team to clamp the circuit during access of the right femoral vein.Venogram of the right femoral vein revealed large amount of thrombus present to the bifurcation.Ivc appeared patent.Argon cleaner wire was placed in the lower common femoral region.Angiovac circuit unclamped and flow rates optimized at 1.5 liters per minute above the ivc filter.Cleaner wire activated in the right femoral.Flow rates dropped to zero.Ct surgeon questioned anesthesia about a non perfusing rhythm.Ekg monitor showed a sinus rhythm of 78.B/p 90's and co2 32.No pulse could be palpated.Vital signs began to rapidly decline.Ct surgeon instructed perfusion to clamp the angiovac circuit.Cpr initiated.Ecmo and full cpb equipment brought to the ir suite.Right femoral arterial access obtained for ecmo placement.Ct surgeon elected to not place the patient on va ecmo in the interventional radiology lab.Patient was immediately transferred to the or with cpr in progress.Follow up with the physician that evening stated that the patient was out of surgery and "stable for now".Follow up on monday, physician stated the patient expired during the weekend.The cause of death was believed to have been a pulmonary embolism and not related to a performance failure of the angiovac device.

Manufacturer Narrative

A review of the device history records was performed for the indicated packaging and picc assembly component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was identified.A supplier corrective action response (scar) was sent to duke empirical, the supplier of the cannula.A review of their supplier lots was performed and there were no observations noted that indicated evidence of a manufacturing defect.The angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.The directions for use (fdu) provided with this device 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".(b)(4).

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING - 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
• MDR Report Key: 7637269
• MDR Text Key: 112293939
• Report Number: 1317056-2018-00122
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• 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,Followup
• Report Date: 08/27/2018

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: Physician
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: H965251860
• Device Lot Number: 5304591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 06/01/2018
• Supplement Dates FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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: 62 YR