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

Model Number 1153

Device Problems Fitting Problem (2183); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/23/2021

Event Type  Injury  

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 Description

It was reported that after the ventricular assist device (vad) was assembled during the implant procedure, the outflow graft strain relief broke while being connected to the pump.It was also reported that the strain relief screw was unscrewed and couldn¿t be tightened.The strain relief was replaced and the implant procedure was completed.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) (hw42341), the associated outflow graft strain relief including the strain relief screw (lot no.Hgr000122), and the surgical tools kit (lot no.T000110) were returned for evaluation.A review of the manufacturing documentation confirmed that the associated outflow graft strain relief met all requirements for release.No performance allegations were made against the vad (hw42341) and surgical tools kit (lot no.T000110).Various analyses were conducted and reviewed in order to evaluate the performance of the received devices in relation to the reported event.Failure analysis of the returned pump revealed that the device passed visual examination, functional testing, and dimensional verification.Failure analysis of the returned surgical tools kit revealed that the returned components passed visual inspection.External visual inspection of the returned outflow graft strain relief revealed that the outflow graft strain relief link containing the clamp was received detached from the rest of the strain relief; however, no damage to the links were observed.The links were able to be assembled back to their appropriate position.Visual inspection also revealed that the strain relief clamp was bent and misaligned.Following the instructions in the instructions for use (ifu), the returned strain relief screw was unable to be tightened within the clamp appropriately and securely.As a result, the reported event was confirmed.Based on the available information and investigation conducted, the reported strain relief damage event can be attributed to handling of the device during assembly.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 Description

It was reported that after the ventricular assist device (vad) was assembled during the implant procedure, the outflow graft strain relief broke while being connected to the pump.It was also reported that the strain relief screw was unscrewed and couldn¿t be tightened.The strain relief was replaced and the implant procedure was completed.No further patient complications have been reported as a result of this event.

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 imf code update 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 - PUMP ACCESSORY
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11740837
• MDR Text Key: 247933787
• Report Number: 3007042319-2021-03387
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1153
• Device Catalogue Number: 1153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 1104 VAD
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 67 KG