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

Model Number G57449

Device Problem Break (1069)

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

Event Date 07/12/2021

Event Type  Injury  

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 Description

A female patient of unknown age underwent a venogram procedure, with access via the left femoral vein, in which the zilver vena venous self-expanding stent, g57449, was used.The physician had a bentson wire, g01063 lot3 13924448, up and into the ivc through a 10fr short sheath, and already crossed the lesion.Then ran an ivus 8fr.035 to size the iliac vein and look at the lesion.Everything tracked fine.After picking an appropriate size catheter, 15 x 140 catheter, the physician advanced the over the bentson wire and the catheter became caught up on the wire at the external iliac.The physician described what felt like something popped in the catheter and it would not advance any further.At this time the called the district manager (dm) into the procedure and the dm requested that he back the device out of the patient.When the physician pulled back on the sheath it broke apart in the patient.The part that remained in the patient was the distal tip still over the wire.The physician was able to pull the wire and sheath tip intact from the patient successfully, at this point it became a diagnostic procedure at this point and the physician decided that the customer has to return that this procedure would be rescheduled.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.Patient will return at a later to do procedure.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Patient will return for another procedure.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.

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 report being submitted due to lab evaluation on (b)(6) 2021.Image review also completed on (b)(6) 2021.This supplement report is being submitted to reflect this.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

Manufacturer Narrative

Common name - qan.Product code - qan.Pma/510(k) # p200023.Device evaluation: the zvt7-35-80-16-140 device of lot number c1828126 involved in this complaint was returned for evaluation, without original packaging.With the information provided, a physical examination and document-based investigation was conducted.Another zvt7-35-80-16-140 device of lot number c1828126 was also returned.This device was not used and was returned in the original packaging.The device related to this occurrence underwent a laboratory evaluation on the 19th august 2021.On evaluation of the device, a break was observed that approx.81.5cm from white connector cap along the outer sheath.The outer sheath returned in two halves.The distal dip that has broken off into the patient has been returned.The stent was returned deployed and undamaged.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 c1828126 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 c1828126.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.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.Inability to advance the delivery system to the target lesion and delivery system fracture cannot be confirmed as imaging of delivery system during advancement and the fragment were not provided.2.The cfv and eiv were unusually tortuous.Additionally, suggested external compression by the left eia would have added to the tortuosity and resisted stent delivery system advancement.3.The delivery system lacked wire and sheath support.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to difficult patient anatomy as the image review confirmed that the cfv and eiv of the patient were unusually tortuous.In addition, external compression by the left eia may have added to the tortuosity and resisted stent delivery system advancement.Furthermore, the delivery system lacked wire and sheath support which may have also contributed to the failure.Complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did experience adverse effects due to this occurrence.The patient will return later to do the procedure once again.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 12299334
• MDR Text Key: 265983880
• Report Number: 3001845648-2021-00601
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574493
• UDI-Public: (01)10827002574493(17)240511(10)C1828126
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57449
• Device Catalogue Number: ZVT7-35-80-16-140
• Device Lot Number: C1828126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2021
• Event Location: Hospital
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: Female