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

Catalog Number ZIV6-35-125-6.0-120-PTX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation: it should be noted that this complaint file is related to three other files.For details of the second, third and fourth investigations please refer to complaint files (b)(4).The ziv6-35-125-6.0-120-ptx device of lot number c775582 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.Lab evaluation ¿ n/a.Document review: prior to distribution ziv6-35-125-6.0-120-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 (b)(4).A review of the manufacturing records for ziv6-35-125-6.0-120-ptx of lot number c775582 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has previously occurred with the current lot number.No action is required as restenosis of the stented artery is listed as a known potential adverse event within the instructions for use and patient pre-existing conditions can cause and/or contribute to the occurrence of restenosis within the stented artery.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c775582.There is no evidence to suggest that the customer did not follow the instructions for use.However, it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the ifu.The (b)(4) packaging insert c-ci1202y06 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.Image review ¿ n/a.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patient¿s pre-existing conditions.From the information provided it is known that the patient had diabetes and hypercholesterolemia amongst other conditions.It is possible that these conditions contributed to restenosis of the stented artery.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient required an additional stent as a result of this event.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

On (b)(6) 2012: ziv6-35-125-6.0-120-ptx/ c777743 x 1 + ziv6-35-125-6.0-120-ptx/ c775582 x1 were placed in the right sfa.(c775582).On (b)(6) 2016: restenosis was confirmed in the right sfa."worsen claudication" was observed.On (b)(6) 2016: another zilver ptx (rpn or lot# unknown) was additionally placed.The patient improved.

• 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 (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 8665905
• MDR Text Key: 146913982
• Report Number: 3001845648-2019-00237
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513454
• UDI-Public: (01)10827002513454(17)140406(10)C775582
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2014
• Device Catalogue Number: ZIV6-35-125-6.0-120-PTX
• Device Lot Number: C775582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/31/2019
• Event Location: Hospital
• Date Manufacturer Received: 05/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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