MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT

Model Number G57455

Device Problem Migration (4003)

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

Event Date 08/10/2021

Event Type  Injury  

Event Description

"common iliac measure 18mm on ivis, external iliac was measuring 14mm with a point of compression between the two.Dr.Musicant chose a 16x140 zilver vena to be carried into the ivc.After deployment we ballooned with a 16mm atlas balloon which was taken to 8 atmosphere which was 2 above nominal.After ballooning we notice the stent had migrated about 40 mm.We called in medtronic with an 18 mm stent to anchor our 16 more distally.When the abre stent went inside the vena, it pushed it up to the proximal common iliac.We were able to land 1 cm of overlap and hold the vena in the common iliac.All in all, the stent migrated over 100 mm (roughly estimated).With anchorage of the 18 mm stent, our final angio looked okay.At this time the patient had not needed an additional surgery." did any unintended section of the device remain inside the patient¿s body? - no · please describe the object and how it was retrieved: did the patient experience a delay or require any additional procedure due to this occurrence? - no · please specify delay or any additional procedure(s) and provide details: has the complainant reported any adverse effects on the patient due to this occurrence? - no has the complainant reported that the product caused or contributed to the adverse effects? - no · please specify adverse effects and provide details.3.94 are images of the device or procedure available? n/a,yes, (no ) 3.95 did the patient have pre-existing conditions? n/a, (yes), no ¿ if yes, please specify: - see this portion in tw 3.96 please describe the native state of the vessel (i.E.Was the anatomy tortuous? - chronic clot at the turn of the external iliac was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other ¿ if other, please specify: 3.97 was a stent previously placed during previous procedures? n/a, yes, (no) 3.98 was the device used percutaneously? n/a,(yes),no 3.99 where on the patient was the percutaneous access site? - groin 3.100 was the access site jugular or femoral? n/a, jugular, femoral other ¿ if other, please specify: - femoral 3.101 what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? - chronic obstruction ¿ if other, please specify 3.102 was the lesion approached via contralateral or ipsilateral? n/a, contralateral, (ipsilateral) 3.103 was pre-dilation performed ahead of placement of the stent? n/a, (yes,) no 3.104 what was the target location for the stent? - distal external iliac 3.105 details of access sheath used (name, fr size, length)? - 9fr teremo pinacle 3.106 was the device flushed through both flushing ports before the procedure, as per ifu? n/a,(yes),no 3.107 details of the wire guide used (name, diameter, hyrdophyllic)? - 260 aqua track 3.108 was resistance encountered when advancing the wire guide to the target location? n/a, (yes) no 3.109 was resistance encountered when advancing the delivery system to the target location? n/a, yes, (no) 3.110 if resistance was met, how did the physician address this? - n/a 3.111 did the tip of the delivery system cross the target location? n/a,(yes),no 3.112 did the user pull the handle towards the hub during deployment, per ifu? n/a,(yes),no 3.113 did the user push the hub during deployment? n/a, yes, (no) 3.114 did the user remove slack in the delivery system before deployment, per ifu? n/a, (yes), no 3.115 was the stent deployed smoothly / without resistance? n/a, (yes), no 3.116 was the stent fully deployed in the patient? n/a, (yes), no 3.117 was the stent fully deployed before removing the delivery system from the patient? n/a, (yes), no 3.118 was post dilation performed after the placement of the stent? n/a, (yes), no 3.119 was the delivery system damaged/kinked/twisted during deployment? n/a, yes, (no) 3.120 what intervention (if any) was required? - see above 3.121 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day - because of the device failure 3.122 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.

Manufacturer Narrative

Pma/510(k) #: p200023.Common name - qan.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #: p200023.Section d: common name - qan.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental mdr being submitted due to confirmation receievd on 16-sept-21 that intervention required to prevent permanent impairment/damage by placing a new stent, report type updated to serious injury.Additional info received 16-sep-2021: what was the size (diameter) of the wire guide that was used for the procedure in which the stent migrated.035 bentson type of wire.What intervention (if any) was required? ¿ device related.An additional product had to be used and placed due to the migration.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? because of the device failure.We deployed an additional stent the same day during the same procedure.No additional procedure on different days were needed to better this patient."common iliac measure 18mm on ivis, external iliac was measuring 14mm with a point of compression between the two.Dr.Musicant chose a 16x140 zilver vena to be carried into the ivc.After deployment we ballooned with a 16mm atlas balloon which was taken to 8atmosphere which was 2 above nominal.After ballooning we notice the stent had migrated about 40mm.We called in medtronic with an 18mm stent to anchor our 16 more distally.When the abre stent went inside the vena, it pushed it up to the proximal common iliac.We were able to land 1cm of overlap and hold the vena in the common iliac.All in all, the stent migrated over 100mm (roughly estimated).With anchorage of the 18mm stent, our final angio looked okay.At this time the patient had not needed an additional surgery.".

Manufacturer Narrative

Pma/510(k) #: p200023.Section d: common name - qan.The zvt7-35-120-16-140 device of lot number c1830613 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Prior to distribution zvt7-35-120-16-140 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 zvt7-35-120-16-140 of lot number c1830613 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 c1830613.There is no evidence to suggest the user did not follow the ifu.However it should be noted that stent migration is listed as a known potential adverse event within the ifu.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patient¿s pre-existing conditions and difficult anatomy.It is known that the patient had a chronic clot at the turn of the external iliac.This could have caused the stent to receive excessive pressure which may have contributed to the migration of the stent.The complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: aisling hassett ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 12433409
• MDR Text Key: 283504931
• Report Number: 3001845648-2021-00652
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574554
• UDI-Public: (01)10827002574554(17)240518(10)C1830613
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2024
• Device Model Number: G57455
• Device Catalogue Number: ZVT7-35-120-16-140
• Device Lot Number: C1830613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/17/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 08/17/2021; 08/17/2021
• Supplement Dates FDA Received: 10/14/2021; 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male