MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number G38482

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Pma/510(k) #p100022/s014.The zisv6-35-125-6-120-ptx device of lot number c1375786 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.It has been confirmed that the complaint device is still with the customer and is pending return.The investigation will be updated once the device has been returned and evaluated.From customer testimony, it is known that the complaint device was advanced over an unknown abbot, hydrophilic wire guide.There was no damage noted on the wire guide.The device was flushed prior to use, as per the ifu.Pre-dilation was conducted prior to deployment.The patient¿s anatomy was heavily calcified.According to information provided, the thumbwheel did not work as intended.The stent was partially deployed and the physician attempted to remove the delivery system, which resulted in stent fracture.There is no evidence to suggest that this incident did not occur.Complaint is confirmed based on the customer¿s testimony.Possible causes for this occurrence include the heavily calcified patient anatomy.The difficult anatomy could have created resistance during deployment, which could have caused or contributed to the failure to deploy the stent.However, as the complaint device has not yet been returned, and the conditions of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.There is no evidence to suggest that the customer did not follow the product instructions for use.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this 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 c1375786.It may be noted that the failure mode of "deployment difficult" has been provisionally assigned.The final failure mode will be confirmed following device return and evaluation.According to information provided, the patient did not experience any adverse effects due to this occurrence.The fractured stent portion was covered with an additional stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

During deployment, the device partially deployed when physician started to try and deploy the rest of the stent.The thumbwheel portion just kept spinning and would not allow the stent to fully deploy.The physician pulled back to remove the stent and it separated.They followed up by stenting over the part that separated and the procedure was completed successfully.

Manufacturer Narrative

(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s014.The device related to this occurrence underwent a laboratory evaluation on the 2nd november 2017.On evaluation of the returned device, it was observed that the exterior portion of the flushing port (flla component) was missing.A bend was observed in the stability sheath, just distal to the strain relief.The distal end of the stent retraction sheath (srs) was shape set in a coil.Crinkles were observed in the distal srs, 5mm apart.The device was returned with a portion of the stent still loaded within the delivery system.The distal end of the stent portion did not have any gold rivets, indicating that the stent was fractured, confirming the customer testimony.The distal end of the srs was 37mm from the distal end of the white tip.A 3.5mm gap was observed between the proximal end of the stent and the pusher ring.The device was returned with the safety trigger depressed.The engineers rotated the thumbwheel mechanism, which rotated freely without further deploying the stent.It was not possible to pass a 0.035¿ diameter wire guide through the remains of the flushing port.The device handle was opened, and the stent retraction wire was observed to be separated from the srs.The flla component was observed to be broken, and it was not possible to pass a wire guide through the flla.The complaint has been confirmed as the failure and was verified in the laboratory.The stent retraction wire was observed to be separated from the stent retraction sheath.Possible causes for this occurrence include the heavily calcified patient anatomy.The difficult anatomy could have created resistance during deployment, which could have caused or contributed to the stent retraction wire separating from the stent retraction sheath, failure to deploy the stent and the stent fracture.It can be noted that the complaint device is contraindicated with lesions that prevent proper placement of the stent.However, as the information has not yet been provided, and the conditions of use cannot be replicated in a laboratory environment, a definitive root cause for this occurrence cannot be determined.It can be noted that as per the product instructions for use: contraindications: ¿patients judged to have a lesion that prevents proper placement of the stent or stent delivery system¿.Prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.Complaint is confirmed as the failure was verified in the laboratory.The stent retraction wire was observed to be separated from the stent retraction sheath.According to information provided, the patient did not experience any adverse effects due to this occurrence.The fractured stent portion was covered with an additional stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the device being returned for evaluation.During deployment, the device partially deployed when physician started to try and deploy the rest of the stent.The thumbwheel portion just kept spinning and would not allow the stent to fully deploy.The physician pulled back to remove the stent and it separated.They followed up by stenting over the part that separated and the procedure was completed successfully.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: michael galvin ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6943542
• MDR Text Key: 89296529
• Report Number: 3001845648-2017-00469
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)180523(10)C1375786
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/15/2017
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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 Weight: 100