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

Model Number G57435

Device Problems Break (1069); Material Separation (1562)

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

Event Date 07/01/2021

Event Type  malfunction  

Event Description

As reported to customer relations via phone conversation "the device went inside the patient and the stent was deployed.But when the physician was taking out the deployment system, the distal tip became detached from the system.The white distal tip remained inside the patient.However, the physician was able to remove the white distal tip as the tip was still attached to the wire.The whole system was removed together, thereby removing everything from the patient." summary of what happened: the delivery system had some resistance while loading it onto the wire, however i think the wire was not properly lubricated (i was busy making sure the tech was flushing the system correctly).We flushed the system again and wiped the wire down generously and it loaded onto the wire with no resistance.After the stent was deployed successfully, the physician and i noticed the distal white tip on the delivery system was missing , while pin and pulling the delivery system out of the patient.The doctor basically tore apart the delivery catheter to make sure it was not in there.Then he was able to pull the sheath out with the wire still in patient and luckily the white tip was on the wire.We were able to successfully remove it.Patient outcome: 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.

Manufacturer Narrative

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

Event Description

Correction report required to update annex f (health impact) code.

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.Device evaluation: the zvt7-35-80-12-140 device of lot number c1827364 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution zvt7-35-80-12-140 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 zvt7-35-80-12-140 of lot number c1827364 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 c1827364.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.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.The physician performing the procedure noted that the patient¿s anatomy was calcified.This may have induced stress/pressure on the tip of the delivery system, causing the tip to break off.Summary: 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.

Manufacturer Narrative

Pma/510(k) #: p200023.Product code: qan.Device evaluation: the zvt7-35-80-12-140 device of lot number c1827364 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution zvt7-35-80-12-140 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 zvt7-35-80-12-140 of lot number c1827364 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 c1827364.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 physician performing the procedure noted that the patient¿s anatomy was calcified.This may have induced stress/pressure on the tip of the delivery system, causing the tip to break off.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

Final mdr being submitted due to completion of the investigation on 18-oct-21.

• 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: 12245201
• MDR Text Key: 283088062
• Report Number: 3001845648-2021-00586
• Device Sequence Number: 1
• Product Code: QAN
• UDI-Device Identifier: 10827002574356
• UDI-Public: (01)10827002574356(17)240507(10)C1827364
• 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: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G57435
• Device Catalogue Number: ZVT7-35-80-12-140
• Device Lot Number: C1827364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/01/2021
• Event Location: Hospital
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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 Sex: Female