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

Model Number	G57439
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
"went to deploy the stent had difficulty initiating / coming out of the catheter.The device was taken out of the patient and placed on the back table.It was still difficult for the stent to come out of the catheter.Note: this is a continuation of previous procedure of a reconstruction of the ivc - stent iliac" 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.Are images of the device or procedure available? n/a,yes,(no) did the patient have pre-existing conditions? n/a, yes, no - see file ¿ if yes, please specify: please describe the native state of the vessel (i.E.Was the anatomy tortuous? - not tortuous.It was fibrotic.Several collaterals was the vessel fibrotic?) n/a, tortuous, calcified, fibrotic, other ¿ if other, please specify: was a stent previously placed during previous procedures? n/a, (yes), no was the device used percutaneously? n/a,(yes),no - jugular access where on the patient was the percutaneous access site? - right jugular access was the access site jugular or femoral? n/a, jugular, femoral other - jugular ¿ if other, please specify: what disease pathology was being treated? may thurner, acute or chronic obstruction, restenosis, other? - venous chronic obstruction ¿ if other, please specify was the lesion approached via contralateral or ipsilateral? n/a, (contralateral), ipsilateral was pre-dilation performed ahead of placement of the stent? n/a, (yes), no what was the target location for the stent? - iliac to fermorla, superior to intersection of the purofunda details of access sheath used (name, fr size, length)? - 8fr cook ansel straight was the device flushed through both flushing ports before the procedure, as per ifu? n/a,(yes),no details of the wire guide used (name, diameter, hyrdophyllic)? - amplatz.035 was resistance encountered when advancing the wire guide to the target location? n/a, yes, (no) was resistance encountered when advancing the delivery system to the target location? n/a, yes, (no) if resistance was met, how did the physician address this? - n/a did the tip of the delivery system cross the target location? n/a,(yes),no did the user pull the handle towards the hub during deployment, per ifu? n/a,(yes),no did the user push the hub during deployment? n/a, yes, (no) did the user remove slack in the delivery system before deployment, per ifu? n/a, (yes), no was the stent deployed smoothly / without resistance? n/a, yes, (no) was the stent fully deployed in the patient? n/a, yes, (no) was the stent fully deployed before removing the delivery system from the patient? n/a, yes, (no) was post dilation performed after the placement of the stent? n/a, yes, no -not, it was removed at this point was the delivery system damaged/kinked/twisted during deployment? n/a, yes, (no) what intervention (if any) was required? - no 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.Were any other defects (other than the complaint issue) observed on the delivery - there was not secondary intervention.The case was continued with a new stent system prior to return (e.G.Kink)? n/a, yes, no ¿ please specify if yes.
Additional 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.
Event or Problem Description
Cancellation report: this event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿, malfunction was determined as low risk indicating no potential for serious injury if the malfunction were to recur.
Additional Manufacturer Narrative
Pma/510(k) #: p200023.Common name: qan.Cancellation report: this event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿, malfunction was determined as low risk indicating no potential for serious injury if the malfunction were to recur.The zvt7-35-120-10-140 device of lot number c1764308 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document-based investigation was conducted.The device related to this occurrence underwent a laboratory evaluation on the 14th of october 2021.On evaluation of the device a kink was observed approx.15 cm from the distal tip on the inner catheter.The device flushed as expected.A 0.035 inch wire guide would not pass beyond the kink.The stent was returned deployed with no damaged observed.Please note that as indicated by the sales representative on 4th of november 2021, the kink discovered on the inner catheter was not seen prior to shipping the device back to cirl.Therefore, it is likely that the kink may have been a result of damage on impact during transportation to cirl.Prior to distribution zvt7-35-120-10-140 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 zvt7-35-120-10-140 of lot number c1764308 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 c1764308.It should be noted that the instructions for use are ifu0091-7.There is no evidence to suggest the user did not follow the ifu.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.The user described the anatomy of the patient as fibrotic with several collaterals.Furthermore, when the device was taken out of the patient the stent was successfully deployed outside of the patients body.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 or Problem Description
Supplemental report being submitted due to lab evaluation and additional information received.Lab evaluation completed on 14-oct-21:kink 15 cm from distal tip of inner catheter.On 04-nov-21, additional info received from rep which indicates that the kink which was apparent in lab evaluation was not seen prior to shipping of device back to cirl and thus the kink may have been as a result of shippping / transportation.
Additional 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.

• 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
• MDR Report Key: 12445668
• Report Number: 3001845648-2021-00659
• Device Sequence Number: 11792227
• Product Code: QAN
• UDI-Device Identifier: 10827002574394
• UDI-Public: (01)10827002574394(17)231007(10)C1764308
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2023
• Device Model Number: G57439
• Device Catalogue Number: ZVT7-35-120-10-140
• Device Lot Number: C1764308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2021
• Event Location: Hospital
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 08/18/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 11/11/2021; 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female