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

Catalog Number VTX-3022

Device Problem Occlusion Within Device (1423)

Patient Problems Thrombus (2101); Transient Ischemic Attack (2109); Low Oxygen Saturation (2477)

Event Date 02/19/2015

Event Type  Injury  

Event Description

As reported on angiovac device: the date of the case was (b)(6) 2015.The patient had an occluded permanent ivc filter (trapease) of unk age.There was no plan nor attempt to remove the filter.It was unk prior to case whether patient had a pfo (the angiovac would never be in or above the ivc filter).Resting cvp prior to the case was approx 4mmhg.A 26fr dryseal was placed in both the rfv [right femoral vein] and the lfv [left femoral vein], a 16 or 18fr reinfusion cannula was placed in the right ij.It was discussed pre-case that low flows should be expected.Flow rates never got above 1 liter/min and averaged 200-300 ml/min.Approximately 1 liter total of normal saline was injected through both of the dryseal sidearms to improve flow rates.Acute, jelly-like thrombus was removed from both the iliac veins with residual thrombus but improved flow around the filter by venogram.Dr.Miller then used a cleaner wire in both iliac veins.Angiovac was used to aspirate this material below the filter.After these passes, there was no thrombus below the filter.Angiovac was still in the left iliac, at about 100ml/min flow.The cleaner wire was reinserted in the right iliac and advanced inside the filter.After a few passes, the patient experienced a sharp increase in cvp, from 8 to 52, with oxygen saturation dropping to the 80's.When the physician was contacted by the clinical specialist after the procedure on (b)(6) 2015, dr.Miller said patient was still intubated but improving.When contacted again on (b)(6) 2015 to follow up on the patient, the physician notified the clinical specialist that patient had experienced a bilateral stroke.He did not say the exact date, but said "the patient had a bilateral in the icu after the angiovac case." he believes that the elevation in right heart pressure caused material to embolize through a pfo" and that they were scheduling an echo.He said by email on (b)(6) 2015 that it was a "significant stroke".

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.Pr #(b)(4).

Manufacturer Narrative

The end user hospital did not report a lot number for the reported event.Based on the attached ship history report (shr) obtained from (b)(4), the hospital only received two (2) lots (# 106711 and 106961) for reported item number vtx-3022 prior to the reported procedure date of (b)(6) 2015.A review of the device history records (dhr) was previously performed by (b)(4) for packaging lot 106711 and 106961 for item number vtx-3022.The dhr reviews performed by (b)(4) revealed no abnormalities for either lot.The angiodynamics complaint report was reviewed for the angiovac product family for the failure mode "patient injury/death."no adverse trend was identified.Since there was no reported device failure, the angiovac cannula sample was not returned for evaluation it, therefore, cannot be determined if the cannula was used in accordance with its labeling.Directions for use is provided with this device and contains the following statements: " 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." without receiving product for evaluation or additional information for the reported event, we are unable to confirm a device malfunction, hence, we cannot definitively determine a root cause for this incident.Attempts were made to obtain additional information regarding this event, however, the additional information requested was not provided.(b)(4).Device not returned to manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & 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: 4629600
• MDR Text Key: 5588077
• Report Number: 2952363-2015-00003
• 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: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VTX-3022
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR