MAUDE Adverse Event Report: ANGIODYNAMICS INC. ANGIOVAC; CATHETER, CANNULA AND TUBING, VASCULAR

Catalog Number VTX-3022

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Low Cardiac Output (2501)

Event Date 01/06/2015

Event Type  Injury  

Event Description

As reported on angiovac device: "ivc filter was placed prior to procedure.Physician decided not to go after saddle pe since patient was stable but prepared for saddle pe removal of ivc.Patient remained stable throughout the entire ivc/it removal.The angiovac cannula became occluded several times during the procedure with large chronic materials being removed from the dry seal sheath.Each time we stayed on pump until the cannula was almost out of the dry seal sheath.Flow rates never got above 1.5 - 1.75.Once the ivc and illiac vein were clean, the flow rate increased to 2.5 1pm.A infia renal ivc filter was placed, sheaths removed and pressure held.While the pressure held, the patients bp dropped.The patient was put on ecmo and taken to surgery.A large piece of thrombosis was removed from the rpa and the patient was kept on ecmo until (b)(6).Patient is stable in icu.Dr.Kim felt that either something got past the av cannula or the increase in blood flow dislodged the saddle pe.The saddle pe was not visualized on the pa gram prior to surgery.The used angiovac device was discarded at the hospital.

Manufacturer Narrative

Although the used device was discarded and will not be returned the investigation into this event is ongoing.Upon completion of the investigation, a supplemental medwatch will be submitted.

Manufacturer Narrative

The device history records were reviewed by (b)(4) (supplier) for packaging lot 106711 for item number vtx-3022 for any deviations.The reviews performed by (b)(4) revealed no abnormalities for this lot.The angiodynamics complaint report was reviewed for the angiovac product family and the failure mode "patient injury/death." no adverse trend was indicated.The used device was discarded at the hospital and was not returned for evaluation.Directions for use provided with the angiovac device contains the following statement: "adverse affects: 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 damage and complications of percutaneous or surgical insertion techniques.These may occur if the instructions for use are not followed." angiodynamics' (b)(4) had a conversation with dr.(b)(6), the reporting physician, regarding the performance of the angiovac device during the procedure and the sequence of events that required the patient to be placed on ecmo.There was no malfunction of the angiovac device during the procedure and it concluded without incident.After exiting the room the patient began to have issues with hypotension.The patient was re-accessed and a pulmonary angiogram revealed fragmentation of the saddle embolus and migration into the right main pulmonary artery.The patient was placed on ecmo and transferred to the intensive care unit.The patient continued to improve on ecmo and medical therapy.The (b)(4) and dr.(b)(6) discussed that the patient's deterioration could be multifactorial.The fragmentation of the saddle embolus can happen with or without the presence of the angiovac.The angiovac was never manipulated into the pulmonary artery.There is a possibility that fragments of the ileocaval thrombus that were not retrieved intraprocedurally might have migrated into the pulmonary artery.This is a known possible complication of any lysis procedure in the ileocaval system.Dr.(b)(6) impression as well as that of their cv surgeon was the patient would recover.(b)(4).Device not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR
• Manufacturer (Section D): ANGIODYNAMICS INC.; marlborough MA
• Manufacturer (Section G): ANGIODYNAMICS; 26 forest street; marlborough MA 01752
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 4495305
• MDR Text Key: 5497548
• Report Number: 2952363-2015-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VTX-3022
• Device Lot Number: 106711-1
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR