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

Model Number G38482

Device Problems Fracture (1260); Activation Failure (3270)

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

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

Pma #p100022/s014.(b)(4).Problem statement: as reported to customer relations, "the thumbwheel stopped working and so the stent would not deploy.A new zilver stent was opened and used to complete the procedure." device evaluation: the zisv6-35-125-6-120-ptx device involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The customer was contacted to request additional information, and to return the device.The investigation will be updated once the information or device are provided.From customer testimony, it is known that the complaint device was advanced over a 0.035¿ diameter terumo wire guide.The patient¿s anatomy was severely calcified and tortuous.The complaint device advanced easily to the target lesion, but encountered difficulty during deployment.Pre-dilation was conducted prior to stent deployment.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the severely calcified or tortuous anatomy.The difficult anatomy could have created resistance during deployment, and caused or contributed to the inability to deploy the stent.However, as the device and information have not yet been provided, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.Document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.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.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.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk will be assessed for this complaint once the device is returned and evaluated.When the risk has been assessed the investigation will be updated with the risk details.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

Initial mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment", ¿deployment difficulty resulting in partial stent deployment¿.As reported to customer relations, "the thumbwheel stopped working and so the stent would not deploy.A new zilver stent was opened and used to complete the procedure.".

Event Description

Follow up mdr is being submitted due to the receipt and evaluation of the device in this event.Mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment", ¿deployment difficulty resulting in partial stent deployment" and "stent retraction wire separated "."the thumbwheel stopped working and so the stent would not deploy.A new zilver stent was opened and used to complete the procedure.".

Manufacturer Narrative

Pma #p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to (b)(4).Importer site establishment registration number: (b)(4).Device evaluation the zisv6-35-125-6-120-ptx device of lot number c1488429 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 complaint device was advanced over a 0.035¿ diameter terumo wire guide.The patient¿s anatomy was severely calcified and tortuous.The complaint device advanced easily to the target lesion, but encountered difficulty during deployment.Pre-dilation was conducted prior to stent deployment.The customer confirmed that the complaint device was advanced over an ipsilateral approach.The target lesion was pre and post dilated.The device was advanced through a short merit 7cm 6fr sheath.The device was flushed prior to use.The target lesion was in the superficial femoral artery (sfa).The device crossed the target lesion prior to deployment.The customer clarified that the patient¿s anatomy was severely calcified, but not tortuous.The stent partially deployed before the thumbwheel mechanism stopped working (ref att.¿dm provides answer to cirl inquiry (b)(4)).The device related to this occurrence underwent a laboratory evaluation on the 2nd august 2018.On evaluation of the returned device, the following observations were made ¿ retraction wire separated from the stent retraction sheath (srs).Missing components (not returned): ¿ flla ¿ stability sheath ¿ srs ¿ proximal inner ¿ overmould ¿ stent.Complaint is confirmed as the failure was verified in the laboratory.The retraction wire was found to be separated from the stent retraction sheath.Possible causes for this occurrence could include the severely calcified anatomy.The difficult anatomy could have created resistance during deployment, and caused or contributed to the retraction wire separating from the stent retraction sheath.The separated wire could have cause the partial stent deployment.However as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0118-3).A capa has been initiated to document and track the actions taken to investigate the stent retraction wire/stent retraction sheath joint separation.Summary complaint is confirmed as the failure was verified in the laboratory.The retraction wire was found to be separated from the stent retraction sheath.The risk was determined to be low (category iii).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.

• 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
• MDR Report Key: 7677449
• MDR Text Key: 113893631
• Report Number: 3001845648-2018-00314
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384825
• UDI-Public: (01)10827002384825(17)190914(10)C1488429
• 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
• Report Date: 08/02/2018

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 Expiration Date: 09/14/2019
• Device Model Number: G38482
• Device Catalogue Number: ZISV6-35-125-6-120-PTX
• Device Lot Number: C1488429
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/14/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/15/2018
• Initial Date FDA Received: 07/11/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR