MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT; VENTRICULAR (ASSIST) BYPASS

Model Number 1125

Device Problems Device Damaged Prior to Use (2284); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy 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.Concomitant medical product: d334drg icd, 693558 lead, 5076-45 lead implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that outflow graft material seemed thinner than usual, and when dilating the graft it very easily frayed, unlike previous implants.It was also noted that the gel at the end of the graft was not apparent, and the graft seemed to look like it was cut with scissors right out of the box.The outflow graft was implanted and remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the outflow graft was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated outflow graft met all requirements for release.The reported event could not be confirmed because the device was not returned and no supporting evidence was provided by the site.Of note, the outflow graft was implanted and remains in use with no further complications reported as a result of this event.Based on the investigation conducted, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.A possible root cause of the reported event may be attributed to user perception.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8487566
• MDR Text Key: 141063553
• Report Number: 3007042319-2019-05300
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000222
• UDI-Public: 00888707000222
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1125
• Device Catalogue Number: 1125
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1103 VAD; 1103 VAD
• Patient Age: 70 YR