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

Catalog Number ZISV6-35-125-7-80-PTX

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 11/29/2016

Event Type  Injury  

Manufacturer Narrative

Pma/510(k)#: p100022/s014.The 1x zisv6-35-125-7-80-ptx of lot c1224320 has not yet been returned for evaluation.With the information provided, a document based investigation was carried out.The investigation will be updated once the device is returned for evaluation.Additional information was provided by the customer.The physician re-intervened on the patient after using pta and placed a balloon expandable stent from boston scientific to crush the stent against the wall of the artery.The vessel regained full flow to the lower extremity.Additional information was requested from the patient, but at the time of the investigation, this information was not available.There is no evidence that this incident did not occur.Therefore, the customer complaint is confirmed based on customer testimony.From customer testimony, this occurrence was due to a malfunction of the thumbwheel mechanism in mid-deployment.This could have possibly occurred due to high deployment forces, which may have been due to a difficult patient anatomy or unknown procedural factors.However, the device has not yet been returned for evaluation, the requested information was not provided and the conditions of use cannot be replicated in the laboratory environment.Therefore, a definitive root cause for this occurrence cannot be determined, and no further comment can be made.The investigation will be updated when the device is returned for evaluation, or if additional information is provided.Prior to distribution all zisv6 (zilver ptx thumbwheel) 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 this lot number.According to information provided, the vessel regained full flow to the lower extremity.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

The facility placed a zilver ptx 7x120 with no incident.The facility went to overlap with a second zilver ptx 7x80 in the right sfa, distal to mid-lesion.Approximately 40 mm's of the stent was deployed.At that point the thumb wheel system broke.The physician asked for the dm to be called and the zilver product manager was called.While they were on the phone speaking with our cook representatives, the physician attempted to pull the entire delivery system (with the stent) out of the patient.The doctor was able to remove the delivery system and the stent, but approximately 20mm's broke off and was left in the patient's common iliac.The broken portion of the device is still inside the patient.The patient embolized the lower leg and was placed on a tpa drip and will be brought back to the lab in the afternoon for re-evaluation.

Manufacturer Narrative

Pma/510(k)#: p100022/s014.The 1x zisv6-35-125-7-80-ptx of lot c1224320 was returned for evaluation, with the open original packaging.With the information provided, a physical examination and document based investigation was conducted.Additional information was provided by the customer.The physician re-intervened on the patient after using pta and placed a balloon expandable stent from boston scientific to crush the stent against the wall of the artery.The vessel regained full flow to the lower extremity.Additional information was requested from the patient, but at the time of the investigation, this information was not available.On evaluation of the returned device, the device handle was opened and it was observed that the retraction wire was separated from the stent retraction sheath (srs).The stent was partially deployed, with 10mm deployed outside the srs.A further 50mm of the stent remained inside the srs.The gold markers were missing, confirming that the distal part of the stent broke off during the removal of the device.It was noted that the returned stent portion measured approximately 60mm in total, confirming that 20mm of the 80mm stent had broken off during the attempted retrieval, as indicated by the customer testimony.The customer complaint is confirmed as the retraction wire was separated from the stent retraction sheath (srs).This occurrence was due to a malfunction of the thumbwheel mechanism in mid-deployment.This could have possibly occurred due to high deployment forces, which may have been due to a difficult patient anatomy or unknown procedural factors.These factors could have caused or contributed to the retraction wire separating from the stent retraction sheath.However, the requested information was not provided and the conditions of use cannot be replicated in the laboratory environment.Therefore, a definitive root cause for this occurrence cannot be determined, and no further comment can be made.Prior to distribution all zisv6 (zilver ptx thumbwheel) 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 c1224320.According to information provided, the vessel regained full flow to the lower extremity.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

This follow up report is being submitted due to the evaluation of the device involved in this event and the update to the conclusion of this investigation.Initial report details: the facility placed a zilver ptx 7x120 with no incident.The facility went to overlap with a second zilver ptx 7x80 in the right sfa, distal to mid-lesion.Approximately 40 mm's of the stent was deployed.At that point the thumb wheel system broke.The physician asked for the dm to be called and the zilver product manager was called.While they were on the phone speaking with our cook representatives, the physician attempted to pull the entire delivery system (with the stent) out of the patient.The doctor was able to remove the delivery system and the stent, but approximately 20mm's broke off and was left in the patient's common iliac.The broken portion of the device is still inside the patient.The patient embolized the lower leg and was placed on a tpa drip and will be brought back to the lab in the afternoon for re-evaluation.

• 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: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6192615
• MDR Text Key: 62913221
• Report Number: 3001845648-2016-00381
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384887
• UDI-Public: (01)10827002384887(17)170225(10)C1224320
• 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: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7-80-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/29/2016
• Event Location: Hospital
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2016
• 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 Age: 73 DA