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Model Number PED-500-16 |
Device Problem
Activation Failure (3270)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received a report that the middle section of the pipeline stent would not open.It was noted the middle section of the stent was positioned in a bend, less than 50% was deployed when it failed to open, and resheathing was done more than twice.The physician tried wagging, but only the straightened anatomy as it would not translate to the stent.The pipeline was removed, and another pipeline was placed with no reported issues.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiography showed the vessel was open.The patient was undergoing surgery for treatment of a saccular, previously ruptured aneurysm of the anterior choroidal with a max di ameter of 4 mm and a 2.5 mm neck diameter.It was noted the patient's vessel tortuosity was severe.Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was 86.Ancillary devices include a 6f cook shuttle, navien 058 guide catheter, phenom 027 microcatheter.
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Manufacturer Narrative
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H3: analysis of the pipeline stent (lot no.A868571) found that there was no pushwire returned with the pipeline flex braid.The distal and proximal ends of the pipeline flex braid were found fully opened and moderately frayed.The middle section of the braid was found fully opened and no damage.No other anomalies were observed.Based on the returned device, the pipeline flex was not confirmed to have failure to open at the middle section as the middle section of the pipeline flex braid was fully opened and no damage.In addition, the distal and proximal ends of the braid were fully opened and frayed.The damage to the braid on the ends of the pipeline flex braid is likely the results of the physician re-sheathing the device more than recommended two times.It is likely that the severe vessel tortuosity may have contributed to the failure to open issue.There was no non-conformance to specifications identified that led to the failure to open issue.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device.Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ h6: conclusion code updated from 67 to d1102.Result code updated from 3221 to c070601.Method code updated from 4114 to b19.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.
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Event Description
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No additional information received.
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Search Alerts/Recalls
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