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

Model Number	G38489
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional 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 section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Problem statement: as reported to customer relations: "patient had a procedure at outpatient facility ((b)(4)) on tuesday, (b)(6) 2018; was admitted to separate facility (unknown what facility at this time on wednesday, (b)(6) 2018 and diagnosed with sepsis.Several cook products were involved with original procedure, unknown and not alleged at this time if any of them may have contributed to this.".Dm may be pulling all product from same lot numbers (as mentioned in product notes field to return for evaluation.Additional information provided by dm on 13jun2018: "i met with customer on monday and so far the report is that the patient was treated with fluids and iv antibiotics and is doing fine with no further complications.The physician was going to try to get the lab results for the strain of strep that was identified in case we need that but it will probably take a few more days." device evaluation: the zisv6-35-125-7-100-ptx device involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.The customer was contacted to request details of any microbiology tests that have been conducted, to help identify which stain of bacteria caused the infection that lead to the patient's sepsis.The investigation will be updated once the information is provided.It may be noted that several devices were used during the procedure.It is not known which, if any, of the devices caused or contributed to the infection and sepsis experienced by the patient.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.A medical advisor provided possible root causes for a similar complaint related to post-procedure infection.The following statements were made: ¿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.¿ several studies have shown that femoral artery infection associated with percutaneous arterial closure devices.¿ ¿¿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.¿ the medical advisor made the following comment in relation to this complaint: "the root cause might be procedure or stent related, but i wouldn¿t suggest that the stent itself was the cause of the sepsis." however, as the device is not available and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.As per the product instructions for use, ¿infection¿ is listed under potential adverse effects.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.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk was determined to be low (category iii).According to the initial reporter, the patient required treatment with fluids and antibiotics due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations: "patient had a procedure at outpatient facility ((b)(4)) on tuesday, (b)(6) 2018; was admitted to separate facility (unknown what facility at this time on wednesday, (b)(6) 2018 and diagnosed with sepsis.Several cook products were involved with original procedure, unknown and not alleged at this time if any of them may have contributed to this." dm may be pulling all product from same lot numbers (as mentioned in product notes field to return for evaluation.Additional information provided by dm on 13jun2018: "i met with customer on monday and so far the report is that the patient was treated with fluids and iv antibiotics and is doing fine with no further complications.The physician was going to try to get the lab results for the strain of strep that was identified in case we need that but it will probably take a few more days.".

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7645728
• Report Number: 3001845648-2018-00290
• Device Sequence Number: 10794528
• Product Code: NIU
• UDI-Device Identifier: 10827002384894
• UDI-Public: (01)10827002384894(17)191128(10)C1460226
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: G38489
• Device Catalogue Number: ZISV6-35-125-7-100-PTX
• Device Lot Number: C1460226
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention