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

COOK IRELAND LTD ZILVER PTX DRUG ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Blood Loss (2597)

Event Type malfunction

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Study: miura t.Drug-eluting versus bare-metal stent implantation with or without cilostazol in the treatment of the superficial femoral artery.The debate in sfa study.Circ cardiovasc interv.2018 aug;11(8):e006564.Event rate @ 1 year: major bleeding= 2 patients.¿85 patients treated with des.Debate in sfa study.The median length of the treated segment was 100 mm (interquartile range, 46.7¿190.0 mm), and 42% were chronic total occlusion lesions.¿ fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Based on limited information, it is cautiously assumed that major bleeding likely required intervention.

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Study: miura t.Drug-eluting versus bare-metal stent implantation with or without cilostazol in the treatment of the superficial femoral artery.The debate in sfa study.Circ cardiovasc interv.2018 aug;11(8):e006564.Event rate @ 1 year: major bleeding= 2 patients ¿85 patients treated with des.Debate in sfa study.The median length of the treated segment was 100 mm (interquartile range, 46.7¿190.0 mm), and 42% were chronic total occlusion lesions.¿ fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.Based on limited iformation, it is cautiously assumed that major bleeding likely required intervention.

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Manufacturer Narrative

Device evaluation: there are 05 complaint files relating to this literature review.The rpn and lot numbers for each are unknown.The 05 complaint files are as follows: (b)(4).This file ((b)(4)) investigates major bleeding.The zilver ptx device of unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a document based investigation was conducted.Document review: as the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution zilver ptx devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that hematoma/haemorrhage is listed as a known potential adverse event within the instructions for use (ifu0117-4).There is no evidence to suggest that the customer did not follow the instructions for use.The japanese packaging insert c-ci1502m02 supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to trauma to the anatomy during the procedure.There is insufficient information to suggest the device caused and/or contributed to the bleeding in this case.As it cannot be confirmed what caused the bleeding and/or if it is device related, a risk assessment will not be completed.Summary: the complaint is confirmed based on customer testimony.The patient outcome is unknown.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

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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

9196667

MDR Text Key

174490532

Report Number

3001845648-2019-00549

Device Sequence Number

Product Code

NIU

Combination Product (y/n)

PMA/PMN Number

P100022

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

company representative,health

Type of Report

Initial,Followup,Followup,Followup,Followup

Report Date

03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

10/16/2019

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

No Information

Device Catalogue Number

UNKNOWN

Device Lot Number

UNKNOWN

Was Device Available for Evaluation?

Was the Report Sent to FDA?

Event Location

Hospital

Date Manufacturer Received

10/09/2019

Is This a Reprocessed and Reused Single-Use Device?

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

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

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