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

Model Number	MCS1725OG
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that during the ventricular assist device (vad) implant procedure, the outflow graft (ofg) exhibited leaking associated with a hole or tiny slit in the ofg.A suture was placed, but the leak was still profound.The ofg was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for device evaluation.Product event summary: the associated outflow graft were returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.A review of manufacturing documentation confirmed that the associated device met all requirements for release.Failure analysis of the returned outflow graft revealed that the device passed visual inspection.As received, a suture was observed to have been placed in the outflow graft, which corresponds with the reported event details; no other anomalies were observed.Further analysis of the outflow graft using optical imaging and scanning electron microscopy did not reveal any obvious damage to fibers.No through-holes or slits were identified in the graft, and separation of the fibers at several points corresponded to the sutures applied during the implant procedure.The reported blood leakage event could not be confirmed due to insufficient evidence.Based on the available information, a possible root cause of the reported event may be attributed to the handling of the graft at implant, leading to disruption of the gel matrix, which led to localized bleeding.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.
Event or Problem Description
It was reported that during the ventricular assist device (vad) implant procedure, the outflow graft (ofg) exhibited leaking associated with a hole or tiny slit in the ofg.A suture was placed, but the leak was still profound.The ofg was exchanged.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for a correction.Corrected fields: h1 type of report: updated to serious injury b1 adv event/product problem updated outcome attributed to adverse event selected in b2 this regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.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
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th avenue; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11668607
• Report Number: 3007042319-2021-03195
• Device Sequence Number: 16893922
• Product Code: DSQ
• UDI-Device Identifier: 00888707007634
• UDI-Public: 00888707007634
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: MCS1725OG
• Device Catalogue Number: MCS1725OG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/08/2021
• Supplement Date Received by Manufacturer: 06/29/2021; 12/08/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 07/14/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MCS1705PU VAD; MCS1705PU VAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 50 KG