Manufacturer's investigation conclusion: incidental findings: review of the submitted photographs showed that there was rescue tape along the driveline.A specific cause for this finding could not be determined through this evaluation.The reported event was confirmed based on an onsite evaluation by an abbott representative, as well as submitted photographs.It was reported that the center requested a clamshell repair.The account submitted photographs that showed a tear in the outer jacket at the distal bend relief of the driveline, near the metal connector.On (b)(6) 2021, an abbott technical services representative successfully performed a clamshell repair.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6).No further related events have been reported at this time.The heartmate ii lvas instructions for use (ifu) and patient handbook contain information on how to care for the driveline.The ifu advises the patient to check the driveline for signs of damage, such as cuts, holes, or tears.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 29dec2016.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) is currently available.This ifu outlines the indications of driveline damage, as well as how to respond to such events.The ifu advises the patient to check the driveline for signs of damage, such as cuts, holes, or tears.The heartmate ii lvas patient handbook is also currently available.Section 4 of this handbook contains information on ¿caring for the driveline.¿ however, all heartmate ii left ventricular assist device (lvad) drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.No further information was provided.The manufacturer is closing the file on this event.
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