MAUDE Adverse Event Report: ANGIODYNAMICS ANGIOVAC; CARDIOPULMONARY BYPASS CANNULA

Catalog Number H965251840

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problems Pulmonary Embolism (1498); Death (1802); Hematoma (1884)

Event Date 04/06/2015

Event Type  Death  

Event Description

As reported by hospital in (b)(6) regarding patient treated with angiovac device: patient admitted in peripheral hospital with pe diagnosis.Systemic lysis which solved the pe, but due to undiagnosed avm, intracranial bleeding and referred to the inselspital in bern on friday (b)(6).Significant dvt diagnosed.Ivc filter placed, but unable to anticoagulate the patient due to the intra cerebral hemorrhagy.Plan to treat with angiovac on tuesday morning in the hybrid room.Monday noon patient is transferred in emergency to the operating room / hybrid room for an urgent angiovac procedure.Massive dvt infra- and supra ivc filter.Angiovac procedure: act > 300; rij and reinfusion in the left ij (distal ivc totally occluded incl.Hepatic and renal veins).Despite aggressive hydration, max.Flow rate 1.4 ltrs./ min.But successful retrieval of thrombotic mass supra-ivc filter.Filter loaded with thrombotic material.Double-stick in the ij for advancing retrieval system for the ivc filter.Note: spasm / hematoma in the ivc.Unclear origin / explanation.Ivc retrieval advanced with angiovac balloon deflated.Retrieval filter under 1.4 ltr suction.Angiovac cannula blocked (o flow) but despite, thrombotic mass moved to the ra/rv/pa.Documented under echo guidance.Attempted to advance cannula in pa.Lunderquist succeeded but not possible to advance cannula.Cpr, ecmo but next day patient died from a massive pe.There were no reports of angiovac cannula or circuit device malfunction during the procedure.(b)(4).

Manufacturer Narrative

The investigation into this event is ongoing.Upon completion of the investigation, a supplemental medwatch will be submitted.

Manufacturer Narrative

Based on the event description, there was no malfunction or performance issue reported for the cannula device, therefore, no review of the device history records was required for the reported lot.The (b)(4) july 2015 complaint report was reviewed for angiovac product family and the failure mode "patient injury/death." no adverse trend was indicated.The physician who performed the angiovac procedure, dr.(b)(6), did not communicate this event as a complaint against the angiovac device or its performance during the procedure.Dr.(b)(6) communicated this event to us to learn from the case and requested that our medical director contact him to discuss.Our (b)(6), has reviewed the event description details and images provided and understands the rationale behind using the angiovac for this patient.Dr.(b)(6) has attempted to contact dr.(b)(6) to provide assistance in reviewing this case.((b)(4)).

• Brand Name: ANGIOVAC
• Type of Device: CARDIOPULMONARY BYPASS CANNULA
• Manufacturer (Section D): ANGIODYNAMICS; marlborough MA
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 26 forest st. ; marlborough MA 01752
• Manufacturer Contact: law ryan ; 26 forest st.; marlborough, MA 01752 ; 5187424488
• MDR Report Key: 4871983
• MDR Text Key: 6046027
• Report Number: 2952363-2015-00006
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K133445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2015

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: 02/28/2015
• Device Catalogue Number: H965251840
• Device Lot Number: 106447
• Other Device ID Number: ANGIOVAC CANNULA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 06/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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