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| Model Number G57449 |
| Device Problems
Improper or Incorrect Procedure or Method (2017); Migration (4003)
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| Patient Problems
Stacking Breaths (1593); Foreign Body Embolism (4439)
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| Event Date 01/28/2022 |
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Event Type
Injury
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Event Description
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Complaint received from dm via e-mail on 31jan2022--did 02feb2022.As reported to customer relations: "today i was made aware of an incident that occurred as a result of a zilver vena c57449 (16x140) stent that was placed by dr.(b)(6) at c43414-4 on (b)(6) 2022.The stent was placed via femoral access without incident however upon arrival home the patient experienced shortness of breath.He was sent to the hospital where it was determined that the stent had migrated to the patient¿s lungs.An emergency surgical procedure was performed by a cardiotheracic surgeon to remove the stent.Additional subsequent procedures may also need to be performed however the patient is stable and walking around post surgery.Senior management and product management have been aware of this incident and have been included in this message.Please reach out with any questions." patient outcome: did any unintended section of the device remain inside the patient¿s body? the entire stent was surgically removed by a cardiothoracic surgeon in an emergency procedure.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? if yes, please describe.Did the patient require any additional procedures due to this occurrence? yes if yes, please describe.Did the product cause or contribute to the need for additional procedures? yes if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? yes.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Aren¿t migrated to heart.Chest had to be opened by a surgeon to retrieve it.Are images of the device or procedure available? n/a, yes, no- yes.Patient/event info - notes: additional information provided by dm on 02feb2022: on what date was the shortness of breath/migration discovered? the day of the procedure (b)(6) 2022 upon arriving home.Is the customer facility reporting this event to the fda? i don¿t believe so.Is a replacement device requested? no.Can the lot # for the device be determined? yes.Is the complaint device available for return? no.Is any other patient information (age, weight, anatomical characteristics, etc.) available? male (b)(6).Did any unintended section of the device remain inside the patient¿s body? if yes, please describe.The entire stent was surgically removed by a cardiothoracic surgeon in an emergency procedure.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? if yes, please describe.Yes.Surgery plus recovery.Has the complainant reported any adverse effects on the patient due to this occurrence? yes.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Aren¿t migrated to heart.Chest had to be opened by a surgeon to retrieve it.Are images of the device or procedure available? n/a, yes, no- yes.Did the patient have pre-existing conditions? n/a, yes, no- not sure if yes, please specify: please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify: nothing out of the ordinary for a venous procedure.Was a stent previously placed during previous procedures? n/a, yes, no- no.Was the device used percutaneously? n/a, yes, no- yes.Where on the patient was the percutaneous access site?- groin.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other?- chronic.If other, please specify.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral- ipsilateral.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no- no.What was the target location for the stent?- common iliac vein.Details of access sheath used (name, fr size, length)?- no sure.Was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no- yes.Details of the wire guide used (name, diameter, hyrdophyllic)?- cook bentson wire 180cm.Was resistance encountered when advancing the wire guide to the target location? n/a, yes, no- no.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no- no.If resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? n/a, yes, no- yes.Did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no- yes.Did the user push the hub during deployment? n/a, yes, no- no.Did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no- yes.Was the stent deployed smoothly / without resistance? n/a, yes, no- yes.Was the stent fully deployed in the patient? n/a, yes, no- yes.Was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no- yes.Was post dilation performed after the placement of the stent? n/a, yes, no- yes.Was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no- no.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no- no.Please specify if yes."--did 03feb2022.3.91 are images of the device or procedure available? n/a, yes, no.3.92 did the patient have pre-existing conditions? n/a, yes, no.If yes, please specify: 3.93 please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify: 3.94 was a stent previously placed during previous procedures? n/a, yes, no.3.95 was the device used percutaneously? n/a, yes, no.3.96 where on the patient was the percutaneous access site? 3.98 what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify.3.99 was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.3.100 was pre-dilation performed ahead of placement of the stent? n/a, yes, no 3.101 what was the target location for the stent? 3.102 details of access sheath used (name, fr size, length)? 3.103 was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no.3.104 details of the wire guide used (name, diameter, hyrdophyllic)? 3.105 was resistance encountered when advancing the wire guide to the target location? n/a, yes, no.3.106 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no.3.107 if resistance was met, how did the physician address this? 3.108 did the tip of the delivery system cross the target location? n/a, yes, no.3.109 did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no.3.110 did the user push the hub during deployment? n/a, yes, no.3.111 did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no.3.112 was the stent deployed smoothly / without resistance? n/a, yes, no.3.113 was the stent fully deployed in the patient? n/a, yes, no.3.114 was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no.3.115 was post dilation performed after the placement of the stent? n/a, yes, no.3.116 was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no.3.117 what intervention (if any) was required? 3.119 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no.Please specify if yes.
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Manufacturer Narrative
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Common name - qan.Product code - qan.Pma/510(k) # p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Manufacturer Narrative
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Common name - qan.Product code - qan.Pma/510(k) # p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Event Description
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Complaint received from dm via e-mail on 31jan2022--did 02feb2022.As reported to customer relations: "today i was made aware of an incident that occurred as a result of a zilver vena c57449 (16x140) stent that was placed by dr.(b)(6) at c43414-4 on (b)(6) 2022.The stent was placed via femoral access without incident however upon arrival home the patient experienced shortness of breath.He was sent to the hospital where it was determined that the stent had migrated to the patient¿s lungs.An emergency surgical procedure was performed by a cardiotheracic surgeon to remove the stent.Additional subsequent procedures may also need to be performed however the patient is stable and walking around post surgery.Senior management and product management have been aware of this incident and have been included in this message.Please reach out with any questions." patient outcome: did any unintended section of the device remain inside the patient¿s body? the entire stent was surgically removed by a cardiothoracic surgeon in an emergency procedure.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? if yes, please describe.Did the patient require any additional procedures due to this occurrence? yes if yes, please describe.Did the product cause or contribute to the need for additional procedures? yes if yes, please specify additional procedures and provide details.Has the complainant reported any adverse effects on the patient due to this occurrence? yes.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Aren¿t migrated to heart.Chest had to be opened by a surgeon to retrieve it.Are images of the device or procedure available? n/a, yes, no- yes.Patient/event info - notes: additional information provided by dm on 02feb2022: on what date was the shortness of breath/migration discovered? the day of the procedure (b)(6) 2022 upon arriving home.Is the customer facility reporting this event to the fda? i don¿t believe so.Is a replacement device requested? no.Can the lot # for the device be determined? yes.Is the complaint device available for return? no.Is any other patient information (age, weight, anatomical characteristics, etc.) available? male (b)(6).Did any unintended section of the device remain inside the patient¿s body? if yes, please describe.The entire stent was surgically removed by a cardiothoracic surgeon in an emergency procedure.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? if yes, please describe.Yes.Surgery plus recovery.Has the complainant reported any adverse effects on the patient due to this occurrence? yes.Has the complainant reported that the product caused or contributed to the adverse effects? please specify adverse effects and provide details.Aren¿t migrated to heart.Chest had to be opened by a surgeon to retrieve it.Are images of the device or procedure available? n/a, yes, no- yes.Did the patient have pre-existing conditions? n/a, yes, no- not sure if yes, please specify: please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify: nothing out of the ordinary for a venous procedure.Was a stent previously placed during previous procedures? n/a, yes, no- no.Was the device used percutaneously? n/a, yes, no- yes.Where on the patient was the percutaneous access site?- groin.What disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other?- chronic.If other, please specify.Was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral- ipsilateral.Was pre-dilation performed ahead of placement of the stent? n/a, yes, no- no.What was the target location for the stent?- common iliac vein.Details of access sheath used (name, fr size, length)?- no sure.Was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no- yes.Details of the wire guide used (name, diameter, hyrdophyllic)?- cook bentson wire 180cm.Was resistance encountered when advancing the wire guide to the target location? n/a, yes, no- no.Was resistance encountered when advancing the delivery system to the target location? n/a, yes, no- no.If resistance was met, how did the physician address this? did the tip of the delivery system cross the target location? n/a, yes, no- yes.Did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no- yes.Did the user push the hub during deployment? n/a, yes, no- no.Did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no- yes.Was the stent deployed smoothly / without resistance? n/a, yes, no- yes.Was the stent fully deployed in the patient? n/a, yes, no- yes.Was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no- yes.Was post dilation performed after the placement of the stent? n/a, yes, no- yes.Was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no- no.Were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no- no.Please specify if yes."--did (b)(6) 2022.3.91 are images of the device or procedure available? n/a, yes, no.3.92 did the patient have pre-existing conditions? n/a, yes, no.If yes, please specify: 3.93 please describe the native state of the vessel (i.E.Was the anatomy tortuous? was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other.If other, please specify: 3.94 was a stent previously placed during previous procedures? n/a, yes, no.3.95 was the device used percutaneously? n/a, yes, no.3.96 where on the patient was the percutaneous access site? 3.98 what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? if other, please specify.3.99 was the lesion approached via contralateral or ipsilateral? n/a, contralateral, ipsilateral.3.100 was pre-dilation performed ahead of placement of the stent? n/a, yes, no 3.101 what was the target location for the stent? 3.102 details of access sheath used (name, fr size, length)? 3.103 was the device flushed through both flushing ports before the procedure, as per ifu? n/a, yes, no.3.104 details of the wire guide used (name, diameter, hyrdophyllic)? 3.105 was resistance encountered when advancing the wire guide to the target location? n/a, yes, no.3.106 was resistance encountered when advancing the delivery system to the target location? n/a, yes, no.3.107 if resistance was met, how did the physician address this? 3.108 did the tip of the delivery system cross the target location? n/a, yes, no.3.109 did the user pull the handle towards the hub during deployment, per ifu? n/a, yes, no.3.110 did the user push the hub during deployment? n/a, yes, no.3.111 did the user remove slack in the delivery system before deployment, per ifu? n/a, yes, no.3.112 was the stent deployed smoothly / without resistance? n/a, yes, no.3.113 was the stent fully deployed in the patient? n/a, yes, no.3.114 was the stent fully deployed before removing the delivery system from the patient? n/a, yes, no.3.115 was post dilation performed after the placement of the stent? n/a, yes, no.3.116 was the delivery system damaged/kinked/twisted during deployment? n/a, yes, no.3.117 what intervention (if any) was required? 3.119 were any other defects (other than the complaint issue) observed on the delivery system prior to return (e.G.Kink)? n/a, yes, no.Please specify if yes.
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Event Description
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Clinical input received 01-mar-2022 confirming this would be considered a life threatening event, section b2 has been updated to reflect this.
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Manufacturer Narrative
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Common name - qan, product code - qan.Pma/510(k) # p200023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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Manufacturer Narrative
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Common name - qan.Product code - qan.Pma/510(k) # p200023.Device evaluation: the device evaluation of zvt7-35-80-16-140 device of lot number c1829820 involved in this complaint could not be completed as the device or photographic evidence of the device was not returned for evaluation.Lab evaluation ¿ n/a.Document review prior to distribution zvt7-35-80-16-140 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zvt7-35-80-16-140 of lot number c1829820 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1829820.It should be noted that the instructions for use (ifu0091) states the following: ¿note: selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration¿.There is evidence to suggest the user did not follow the ifu.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: the complaint is not confirmed as imaging of the event was not provided.The stent was undersized along part of the stented segment.The lesion was likely not a classic may-thurner lesion.Root cause review: a definitive root cause of user error can be concluded based on the available information.From the image review it was ascertained that the stent size selected was undersized along part of the stented segment.As per ifu, inappropriate stent size selection can lead to stent migration.Summary: the customer¿s testimony could not be confirmed however the complaint is confirmed based on the failure verified in the investigation.The customer testimony of 'stent migration' cannot be confirmed based on the image review because the imaging event is not shown however, the image review has indicated that the stent was undersized along part of the stented segment.This may have caused or contributed to stent migration.According to the initial reporter, the patients chest had to be opened by a surgeon to retrieve the migrated stent and additional subsequent procedures may also need to be performed however the patient is stable and walking around post ¿ surgery.Complaints of this nature will continue to be monitored for potential emerging trends.
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Event Description
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Supplemental report is being submitted due to the completion of the investigation.
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Event Description
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Supplemental report is being submitted due to the correction of the annex c code on 12-sep-2023.C13 - operational problem identified updated to c23 - usage problem identified.
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Manufacturer Narrative
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Pma/510(k) #p200023 device evaluation the device evaluation of zvt7-35-80-16-140 device of lot number c1829820 involved in this complaint could not be completed as the device or photographic evidence of the device was not returned for evaluation.Lab evaluation ¿ n/a document review prior to distribution zvt7-35-80-16-140 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for zvt7-35-80-16-140 of lot number c1829820 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1829820.It should be noted that the instructions for use (ifu0091) states the following: ¿note: selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration¿.There is evidence to suggest the user did not follow the ifu.Image review images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression 1.The complaint is not confirmed as imaging of the event was not provided.2.The stent was undersized along part of the stented segment.3.The lesion was likely not a classic may-thurner lesion root cause review a definitive root cause of user error can be concluded based on the available information.From the image review it was ascertained that the stent size selected was undersized along part of the stented segment.As per ifu, inappropriate stent size selection can lead to stent migration.Summary the customer¿s testimony could not be confirmed however the complaint is confirmed based on the failure verified in the investigation.The customer testimony of 'stent migration' cannot be confirmed based on the image review because the imaging event is not shown however, the image review has indicated that the stent was undersized along part of the stented segment.This may have caused or contributed to stent migration according to the initial reporter, the patients chest had to be opened by a surgeon to retrieve the migrated stent and additional subsequent procedures may also need to be performed however the patient is stable and walking around post ¿ surgery.Complaints of this nature will continue to be monitored for potential emerging trends.
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