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

Catalog Number ZISV6-35-125-6.0-120-PTX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).Pma/510(k) #p100022/s014.The zisv6-35-125-6.0-120-ptx device of lot number c1390363 involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The investigation will be updated if the device is returned and evaluated at a later date.The customer was contacted to provide additional information.The information has not yet been provided.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The information from this occurrence was reviewed by a medical advisor.The following comments were made.¿¿infection¿ is listed in the ifu at the section of ¿potential adverse events¿.But the ifu doesn¿t specify where the infection occurs (local or systematic) except ¿infection/abscess formation at access site¿.There are a few things that could contribute to the infection; theoretically, stent deployment could injury the intima and may act as a nidus for bacterial adherence, thus establishing an environment for microbial colonization.Stent infection is exceedingly rare.According to a physician that i spoke with, he reckons most infection in femoral artery is procedure-related or stent got contaminated during the procedure.Repeat femoral artery puncture or indwelling sheath times could also increase the risk of infection.Immunocompromised patients prone to infection.Not sure how hemostasis was performed in this patients.Several studies have shown that femoral artery infection associated with percutaneous arterial closure devices.Has blood culture been done for this patient? what organism caused this infection?¿ in addition, the following comments were also made by the medical science officer: ¿¿vascular stent infections are rare, but they do happen.As he also pointed out, it doesn¿t necessarily arise from the stent not being sterile in its package, but perhaps from bacteria being introduced into the bloodstream during the procedure and then infecting the stent.Based on the language from the complaint (¿a serious located infection was detected at the position of the ptx¿), i¿d tend to conclude the infection was ¿stent-related,¿ but i wouldn¿t suggest that the stent itself was the cause of the infection.¿ based on the above, possible causes for this occurrence could include the complaint device becoming contaminated during the procedure, the procedural method, a compromised patient immune system or injury to the vessel acting as a nidus for bacterial adherence.However, the device has not yet been returned for evaluation, the information has not yet been provided and the circumstances of use cannot be replicated in a laboratory environment.Therefore, a definitive root cause for this occurrence cannot be determined.As per the product instructions for use, infection is listed under potential adverse effects.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 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 c1390363.According to the initial reporter, it is known that the patient required that the infected stent to be explanted and a femoral artery bypass was conducted as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

On the (b)(6) 2017, the physician implanted a zilver ptx between the (b)(6) 2017.The patient had severe pain in his thigh, he was admitted on (b)(6) 2017 at urgency service and was transferred to infectious disease dep.A serious located infection was detected at the position of the ptx so; the vascular surgeon decided to explant it the (b)(6) 2017.The vascular surgeon decided to explant the stent and kept a part of the explanted stent for us to analysis.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).Pma/510(k) #p100022/s014.A follow-up mdr is being submitted to include the device evaluation details.The zisv6-35-125-6.0-120-ptx explanted stent portion of lot number c1390363 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.On evaluation of the returned device, it was noted that only a portion of the stent was returned, measured as 42mm long.Both ends of the stent were fractured off, and were not returned with the stent portion.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The information from this occurrence was reviewed by a medical advisor.The following comments were made: ¿¿infection¿ is listed in the ifu at the section of ¿potential adverse events¿.But the ifu doesn¿t specify where the infection occurs (local or systematic) except ¿infection/abscess formation at access site¿.There are a few things that could contribute to the infection; 1.Theoretically, stent deployment could injury the intima and may act as a nidus for bacterial adherence, thus establishing an environment for microbial colonization.2.Stent infection is exceedingly rare.According to a physician that i spoke with, he reckons most infection in femoral artery is procedure-related or stent got contaminated during the procedure.Repeat femoral artery puncture or indwelling sheath times could also increase the risk of infection.3.Immunocompromised patients prone to infection.4.Not sure how hemostasis was performed in this patients.Several studies have shown that femoral artery infection associated with percutaneous arterial closure devices.5.Has blood culture been done for this patient? what organism caused this infection?¿ in addition, the following comments were also made by the medical science officer.¿¿vascular stent infections are rare, but they do happen.As he also pointed out, it doesn¿t necessarily arise from the stent not being sterile in its package, but perhaps from bacteria being introduced into the bloodstream during the procedure and then infecting the stent.Based on the language from the complaint (¿a serious located infection was detected at the position of the ptx¿), i¿d tend to conclude the infection was ¿stent-related,¿ but i wouldn¿t suggest that the stent itself was the cause of the infection.¿ based on the above, possible causes for this occurrence could include the complaint device becoming contaminated during the procedure, the procedural method, a compromised patient immune system or injury to the vessel acting as a nidus for bacterial adherence.However, the information has not been provided and the circumstances of use cannot be replicated in a laboratory environment.Therefore, a definitive root cause for this occurrence cannot be determined.As per the product instructions for use, infection is listed under potential adverse effects.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 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 c1390363.According to the initial reporter, it is known that the patient required that the infected stent to be explanted and a femoral artery bypass was conducted as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

A follow-up mdr is being submitted to include the device evaluation details.Initial report details: on the (b)(6) 2017, the physician implanted a zilver ptx between the (b)(6) 2017.The patient had severe pain in his thigh, he was admitted on (b)(6) 2017 at urgency service and was transferred to infectious disease dep.A serious located infection was detected at the position of the ptx so the vascular surgeon decided to explant it the (b)(6) 2017.The vascular surgeon decided to explant the stent and kept a part of the explanted stent for us to analysis.

• 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
• Manufacturer Contact: michael galvin ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7056804
• MDR Text Key: 92838519
• Report Number: 3001845648-2017-00564
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352855
• UDI-Public: (01)10827002352855(17)190224(10)C1390363
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-6.0-120-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: 11/23/2017
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2017
• 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