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

Model Number 1125

Device Problems Leak/Splash (1354); Misassembled (1398); Material Split, Cut or Torn (4008)

Patient Problems Hemorrhage/Bleeding (1888); No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

Additional products: brand name: heartware ventricular assist system - strain relief, medical device: model #: 1153 / catalog #: 1153/ expiration date: unk / serial #: udi #: (b)(4).Device available for evaluation? no.Device: mfg date: unk.Labeled for single use? no.(b)(4).Additional information has been requested regarding the vad serial number of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the outflow graft had a needle hole/tear, and the patient experienced bleeding.The surgeon was required to disconnect the outflow graft strain relief in order to get to the hole in the outflow graft.The surgeon was unable to reconnect the outflow graft strain relief again, and the surgeon secured the strain relief with a suture.The surgeon also sutured the needle hole on the outflow graft.The outflow graft remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This supplemental is being submitted for additional information received.Serial number was added for 1153 vad.Additional products: expiration date: 31-dec-2021/ serial or lot#: (b)(6); udi#: (b)(4); h4: mfg date: 31-dec-2019.Investigation of this event is pending and a supplemental report will be sent upon its completion.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.

Manufacturer Narrative

A supplemental report is being submitted for investigation summary.Product event summary: the outflow graft and the implant kit associated with the ventricular assist device (vad) were not returned for evaluation.The reported event could not be confirmed as devices were not returned and no supporting evidence was provided by the site.Based on historical review of similar events, the most likely root cause of tears or cuts in the outflow graft has been attributed to design issues.Based on the available information a possible root cause of the reported inability to link the strain relief can be attributed to assembly technique in the field.Additional products: serial or lot#: hw36874 h6: patient ime code(s): e0506 h6: imf code(s): f12, f23 h6: fda device code(s): a2305 h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d12, d14 investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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: 10770238
• MDR Text Key: 214104959
• Report Number: 3007042319-2020-07158
• Device Sequence Number: 1
• Product Code: DSQ
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 1125
• Device Catalogue Number: 1125
• Device Lot Number: 2002815930
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1104 VAD.; 1104 VAD
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 125