MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM; CIRCULATORY ASSIST SYSTEM

Catalog Number 1125

Device Problem Cut In Material (2454)

Patient Problem Blood Loss (2597)

Event Date 06/11/2013

Event Type  Injury  

Manufacturer Narrative

The outflow graft (0001686065), was not returned to manufacturer for analysis.Products with the same reported event were examined by vascutek, who manufacturers the outflow graft.Review of the porosity results for the outflow graft revealed that it met specifications.Moreover, the gelweave is chemically impregnated in batches.If a unit fails, then it is expected that all units from that chemical batch will fail.Four complaints from different batches were observed and no other complaints from the same chemical batch have been reported with a similar failure or concern.Moreover, three of the four complaints are from a single institution.The most probable root cause of the reported outflow graft tearing is due to a tensile break of the fibres but what caused the tensile break to take place could not be determined from the testing conducted at the manufacturer; multiple factors may have contributed to the reported event including but not limited to inadequate instruction for use, outflow graft installation technique, and/or design issues.The ventricular assist system is indicated for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings, including transportation.Bleeding.Not sufficiently loosening the graft clamp screw when placing the graft strain relief over the outflow graft and pump outflow may lead to a circumferential break on the outflow graft.Ifu00001 rev 15/ifu00098 rev 04, indicates that the graft clamp screw should be loosened to allow the graft clamp to be placed over the pump outflow conduit.Heartware is submitting this correction to a previously submitted mdr report as a result of remediation activities related to fda warning letter fla-14-14, dated june 2, 2014, and pursuant to the provisions of 21 cfr part 803.

Event Description

During lvad implantation, the patient's hvad pump was implanted in a diaphragmatic position.The pump was turned on and its speed was slowly increased to 2500rpm.Shortly thereafter blood began pooling in the pericardium.A slice in the graft was noted approximately 1cm distal to the pump housing.The pump was stopped at this time and removed from the patient.After removal from the patient, the outflow graft and bend relief were disassembled.The section of the graft containing the hole was cut off.The pump was re-assembled in the surgical field and it was replaced into the patient's left ventricle.The pump was then started at 1800rpm, de-airing was performed and the procedure was completed without any reported injury.The patient is recovering in the intensive care unit and is reported to be doing well.Of note, there was no observed effect on the patient other than prolonged bypass time.The product will not be returned for further analysis.No further information is available at this time.

Manufacturer Narrative

Supplemental mdr report is being submitted to include the associated fda z-number issued for the reported issue captured in this report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Type of Device: CIRCULATORY ASSIST SYSTEM
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer (Section G): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• Manufacturer Contact: nathalie nunez ; 14400 nw 60th avenue; miami lakes, FL 33014-3105 ; 3053641538
• MDR Report Key: 6081540
• MDR Text Key: 59285934
• Report Number: 3007042319-2016-03890
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 1125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-2058-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention