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

Catalog Number ZISV6-35-80-5.0-120-PTX

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.¿the surgeon had trouble passing wires guides and a balloon beyond the lesion.He then managed to cross the lesion although it was very heavily calcified.He proceeded to deploy the stent although the stent did not fully open/flower at the distal end and the thumbwheel became stiff and was unable to deploy the stent.The surgeon then had to try and remove the system off the wire although the stent became stuck and ended up breaking in half.¿ the zisv6-35-80-5.0-120-ptx device of unknown lot number involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that the fractured stent portion was affixed to the vessel wall by post-dilation with a balloon.The customer was contacted to return the complaint device.At the time of the investigation, the complaint device has not yet been returned.The investigation will be updated once the device is returned and evaluated.The customer was contacted to request additional information.Further requests will be made and the investigation will be updated if the information is provided.The area representative was contacted to help determine the lot code of the complaint device.The investigation will be updated once the lot code has been identified.There is no evidence to suggest that this incident did not occur, the complaint is confirmed based on the customer¿s testimony.Possible cause for this occurrence could be the difficult patient anatomy.From customer testimony, it is known that the target location was very heavily calcified.A difficult anatomy could have created resistance encountered during advancement and during deployment, which could have caused or contributed to the difficult deployment, resulting in the partial deployment and subsequent fracture of the stent.However, as the complaint device has not yet been returned, 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.There is no evidence to suggest that the customer did not follow the product instructions for use.The lot number of the complaint device is unknown.However, from customer testimony, a component lot number is known.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.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.There is no evidence to suggest that this incident did not occur.Complaint is confirmed based on the customer¿s testimony.According to information provided, the patient did not experience any adverse effects due to this occurrence.The broken stent portion was affixed to the vessel wall by post dilation with a balloon.The risk will be assessed for this complaint once the device has been returned and evaluated by research and development, and the additional information has been provided.When completed, the investigation will be updated with the risk details.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture".The surgeon had trouble passing wires guides and a balloon beyond the lesion.He then managed to cross the lesion although it was very heavily calcified.He proceeded to deploy the stent although the stent did not fully open/flower at the distal end and the thumbwheel became stiff and was unable to deploy the stent.The surgeon then had to try and remove the system off the wire although the stent became stuck and ended up breaking in half.

Manufacturer Narrative

This follow up report is being submitted to inform fda that the device has been received, the lot number has been confirmed and a lab evaluation is pending.A follow up mdr will be submitted within 30 days with the final investigation conclusions.Cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Mfr site: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p100022/s014, initial investigation details: ¿the surgeon had trouble passing wires guides and a balloon beyond the lesion.He then managed to cross the lesion although it was very heavily calcified.He proceeded to deploy the stent although the stent did not fully open/flower at the distal end and the thumbwheel became stiff and was unable to deploy the stent.The surgeon then had to try and remove the system off the wire although the stent became stuck and ended up breaking in half.¿ the zisv6-35-80-5.0-120-ptx device of unknown lot number involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that the fractured stent portion was affixed to the vessel wall by post-dilation with a balloon.The customer was contacted to return the complaint device.At the time of the investigation, the complaint device has not yet been returned.The investigation will be updated once the device is returned and evaluated.The customer was contacted to request additional information.Further requests will be made and the investigation will be updated if the information is provided.The area representative was contacted to help determine the lot code of the complaint device.The investigation will be updated once the lot code has been identified.There is no evidence to suggest that this incident did not occur, the complaint is confirmed based on the customer¿s testimony.Possible cause for this occurrence could be the difficult patient anatomy.From customer testimony, it is known that the target location was very heavily calcified.A difficult anatomy could have created resistance encountered during advancement and during deployment, which could have caused or contributed to the difficult deployment, resulting in the partial deployment and subsequent fracture of the stent.However, as the complaint device has not yet been returned, 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.There is no evidence to suggest that the customer did not follow the product instructions for use.The lot number of the complaint device is unknown.However, from customer testimony, a component lot number is known.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.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.There is no evidence to suggest that this incident did not occur.Complaint is confirmed based on the customer¿s testimony.According to information provided, the patient did not experience any adverse effects due to this occurrence.The broken stent portion was affixed to the vessel wall by post dilation with a balloon.The risk will be assessed for this complaint once the device has been returned and evaluated by research and development, and the additional information has been provided.When completed, the investigation will be updated with the risk details.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted to inform fda that the device has been received, the lot number has been confirmed and a lab evaluation is pending.A follow up mdr will be submitted within 30 days with the final investigation conclusions.Initial mdr details: initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture".The surgeon had trouble passing wires guides and a balloon beyond the lesion.He then managed to cross the lesion although it was very heavily calcified.He proceed to deploy the stent although the stent did not fully open/flower at the distal end and the thumbwheel became stiff and was unable to deploy the stent.The surgeon then had to try and remove the system off the wire although the stent became stuck and ended up breaking in half.

Manufacturer Narrative

This follow up report is being submitted to inform fda that the device has been received, the lot number has been confirmed and a lab evaluation is pending.A follow up mdr will be submitted within 30 days with the final investigation conclusions.(b)(4).Exemption number: e2016031.(b)(4) pma/510(k) # p100022/s014 the zisv6-35-80-5.0-120-ptx device of lot number c1318055 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, it is known that the fractured stent portion was affixed to the vessel wall by post-dilation with a balloon.The complaint device was advanced over a 0.035¿ diameter, hydrophilic terumo wire guide.The customer cannot recall if the wire guide was wiped between uses.The device was flushed prior to use.The physician performed a pre-dilation prior to stent deployment, but stated that the dilation did not give a good result.The area representative confirmed that the lot code of the device is c1318055 the device related to this occurrence underwent a laboratory evaluation on the 30th november 2017.On evaluation of the returned device, it was observed that the delivery system was returned without the stent.However, this observation was in error, as the stent was available but not evaluated in error.The safety trigger was depressed and the stent retraction sheath (srs) was fully retracted.Bends were observed in the stability sheath.A kink was noted in the distal inner, which could have occurred during transport.There was no evidence of any manufacturing defects.The device was difficult to flush, due to congealed blood in the device lumen, and the kink in the distal inner.A wire guide was passed through the device, and resistance was encountered at the kink in the distal inner, with congealed blood seen exiting the device.¿fish mouth¿ damage was observed on the distal white tip, indicating that the device had passed through difficult patient anatomy.It was found that the stent from the complaint device was not evaluated in error.The stent underwent a laboratory evaluation on the 4th january 2018.On evaluation of the stent, it was observed that there was evidence that the stent was fractured.The stent portion was measured as 8.5cm in length.There was no other damage noted on the stent.It was suggested that the stent was fractured as the delivery system was withdrawing from the patient.Complaint is confirmed as the failure was verified in the laboratory.The stent was found to be fractured.Possible cause for this occurrence could be the difficult patient anatomy.From customer testimony, it is known that the target location was very heavily calcified.A difficult anatomy could have created resistance encountered during advancement and during deployment, which could have caused or contributed to the difficult deployment, resulting in the partial deployment and subsequent fracture of the stent.However, as 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 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 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.Complaint is confirmed as the failure was verified in the laboratory.The stent was found to be fractured.According to information provided, the patient did not experience any adverse effects due to this occurrence.The broken stent portion was affixed to the vessel wall by post dilation with a balloon.The risk was determined to be low (category iii).Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted to inform fda of the final investigation conclusions.Initial mdr details: initial mdr is being submitted based on the device malfunction precedence: ¿stent fracture".The surgeon had trouble passing wires guides and a ballon beyond the lesion.He then managed to cross the lesion although it was very heavily calcified.He proceded to deploy the stent although the stent did not fully open/flower at the distal end and the thumbwheel became stiff and was unable to deploy the stent.The surgeon then had to try and remove the system off the wire although the stent became stuck and ended up breaking in half.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7036429
• MDR Text Key: 93301329
• Report Number: 3001845648-2017-00551
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-80-5.0-120-PTX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 11/22/2017; 12/19/2017
• Supplement Dates FDA Received: 12/19/2017; 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1