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Model Number PED-500-30 |
Device Problem
Activation Failure (3270)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/27/2020 |
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 of the pipeline stent was kinked and could not be deployed after repeated adjustments.Once removed from the patient, it was found the middle section was kinked, and it still could not be opened outside of the body.It was indicated that all devices were prepared/flushed as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Post-procedure angiographic results showed a part of the contrast agent remained.The patient was undergoing surgery for treatment of a saccular, unruptured, left side aneurysm with a max diameter of 12.1mm and a 2.3mm neck diameter.It was noted the patient's vessel tortuosity was moderate.Ancillary devices include a cook 6f long sheath, 5f navien microcatheter, marksman microcatheter, synchro-14 guidewire.
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Manufacturer Narrative
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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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Additional information received reporting that there were no complications in the procedure prior to the pipeline stent failure to o pen.The stent was not placed in a vessel bend.The microcatheter and intracranial support catheter were shaken to encourage the pipeline to open but this was not successful.The pipeline was removed and a coil embolization procedure was performed instead.
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Manufacturer Narrative
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H3: the pipeline flex embolization device (model: ped-500-30 lot: a810952) and marksman catheter (model: fa-55150-1030 lot: 218379403) were returned for analysis.The pushwire was protruding from the hub ~51.5cm and the tip coil was partially deployed from catheter tip.The pipeline flex could not be pushed forward or removed.For further examination, the catheter was cut to remove the pipeline flex from the catheter lumen.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.When pushing the pipeline flex braid out from the catheter lumen, the distal and proximal ends of the pipeline flex braid appeared to be fully opened and moderately frayed.In addition, the middle section of the pipeline flex braid appeared fully opened and no damage.No bent or kink were found with the pusher.No damages were found with the distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.The total and usable lengths of the catheter were measured to be within specifications.The catheter tip and marker were e xamined; and no damages were found.The catheter body found to be accordioned at ~7.5cm and ~18.0cm from the distal tip.No flash or voids molded were observed in the hub.The catheter was then tested by running an in-house 0.0265¿ mandrel through catheter tip and hub.The mandrel successfully passed through the catheter hub and tip with no issues; however, the resistance observed at the damaged locations.Based on the customer's report and returned device, the pipeline flex could not be confirmed to have failure to open at the middle end as the middle section of the pipeline flex braid appeared fully opened and no damage.Furthermore, the returned pipeline flex was also found to be stuck inside the marksman catheter.The pipeline flex pushwire and catheter were also found to be damaged.From the damages seen on the catheter body (accordioning), pipeline flex braid (fraying) and hypotube (stretching); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retrieve the pipeline flex through the catheter against resistance.It is possible that the damaged braid may have contributed to the failure to open issue.However, the cause for resistance could not be determined.It is possible that the moderate vessel tortuosity may have contributed to this event.Based on the returned devices, there was no non-conformance to specifications identified that led to the failure to open issue.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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