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

Catalog Number ZIV6-35-125-7.0-120-PTX

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  Injury  

Manufacturer Narrative

Cook (b)(6) ltd (manufacturer) is submitting this report on behalf of(b)(4).Pma/510(k) #p100022/s001.This investigation captures the fracture of ziv6-35-125-7.0-120-ptx stent of lot number c775671 on the (b)(6) 2017.Reference also report # 3001845648-2017-00490.The patient had the following pre-existing conditions: hypertension, hypercholesterolemia, coronary artery disease, pulmonary artery disease, previous smoker (current not).The device was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.Imaging review is currently pending for this patient.The investigation will be updated following the receipt of the imaging review.There is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.It can be noted that according to clinical opinion received for a similar complaint "there are a number of potential risk factors that could result in stent fracture.To start with, the superficial femoral artery itself is subject to all sorts of forces ¿ bending, twisting, stretching, compressing, etc.¿ which can put stress on stents in this artery, resulting in fractured.Additional potential risk factors for stent fracture that have been identified or suggested include lesion length (longer lesions have greater risk), total occlusions, placement of stent close to a joint (hip or knee), overlapping of stents, and calcification of the vessel.".However as the imaging review is currently pending for this complaint a definite root cause cannot be determined at this time.It may be noted that according to packaging insert stent strut fracture is a known potential adverse event associated with the placement of this device.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 the lot number c775671.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c775671.There were no additional procedures required as a result of this event.The physician determined to take wait-and-see approach.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

On (b)(6) 2012: two ptx stents were placed, overlapped each other, in the left sfa of the patient: ziv6-35-125-7.0-120-ptx lot#:c775671, ziv6-35-125-7.0-120-ptx lot#:c775588.On (b)(6) 2017: x-ray imaging confirmed type 2 stent fracture in the middle portion of the stent placed in the distal part.The order of the stent placement is unknown, meaning it is impossible to find out which of the two lot# the relevant frunctured device is.As the artery was patent and no problems in the blood flow, the physician determined to take wait-and-see approach.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00490.

Manufacturer Narrative

(b)(4).Exemption number: e2016031 importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) #p100022/s001.This follow up mdr is being submitted due to the receipt and review of images relating to this event.This investigation captures the fracture of ziv6-35-125-7.0-120-ptx stent of lot number c775671 on the 31-aug-2017.Reference also report # 3001845648-2017-00490.The patient had the following pre-existing conditions: hypertension, hypercholesterolemia, coronary artery disease, pulmonary artery disease, previous smoker (currect:not).The device was implanted in the patient and is therefore unavailable for evaluation.With the information provided a document based investigation was carried out.Images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: findings: a single image of the left proximal superficial femoral artery stents was provided along with the complaint report.The inferior stent shifted medial between the proximal and mid thirds of the stent.The shift was approximately medial over the course of approximately 8mm.Slight diameter contraction at the shift suggests twisting.The mid superior stent demonstrated a similar less acute shift.Image quality was insufficient to resolve individual inferior stent elements with complete obscuration through some portions of the stent.Impression: although the inferior stent shifted acutely medial, a stent fracture cannot be confirmed as image quality was too poor to resolve individual stent elements.Significant findings relative to the patient's anatomy were not observed.Significant findings relative to the disease state were not observed.Significant findings relative to the use of the device were not observed.Significant findings relative to the design or performance of the device were not observed.Cause of adverse events was not observed.As the image quality it too poor to confirm if stent fracture occurred, the complaint is confirmed based on customer testimony.It can be noted that according to clinical opinion received for a similar complaint "there are a number of potential risk factors that could result in stent fracture.To start with, the superficial femoral artery itself is subject to all sorts of forces ¿ bending, twisting, stretching, compressing, etc.¿ which can put stress on stents in this artery, resulting in fractured.Additional potential risk factors for stent fracture that have been identified or suggested include lesion length (longer lesions have greater risk), total occlusions, placement of stent close to a joint (hip or knee), overlapping of stents and calcification of the vessel." it may be noted that according to packaging insert, stent strut fracture is a known potential adverse event associated with the placement of this device.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 the lot number c775671.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c775671 there were no additional procedures required as a result of this event.The physician determined to take wait-and-see approach.Complaints of this nature will continue to be monitored for any potential emerging trends.

Event Description

This follow up mdr is being submitted due to the receipt and review of images relating to this event.Initial report details: on (b)(6) 2012 - two ptx stents were placed, overlapped each other, in the left sfa of the patient.Ziv6-35-125-7.0-120-ptx lot#: c775671; ziv6-35-125-7.0-120-ptx lot#: c775588.On (b)(6) 2017 - x-ray imaging confirmed type 2 stent fracture in the middle portion of the stent placed in the distal part.The order of the stent placement is unknown, meaning it is impossible to find out which of the two lot# the relevant frunctured device is.As the artery was patent and no problems in the blood flow, the physician determined to take wait-and-see approach.As 2 stents are suspected to be involved in this event a separate report has been submitted for each suspect device.Reference also report # 3001845648-2017-00490.

• 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: 6983235
• MDR Text Key: 90420659
• Report Number: 3001845648-2017-00489
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002513539
• UDI-Public: (01)10827002513539(17)140501(10)C775671
• Combination Product (y/n): N
• 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: 10/25/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: ZIV6-35-125-7.0-120-PTX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2017
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/25/2017
• Supplement Dates FDA Received: 11/22/2017
• Date Device Manufactured: 06/11/2012
• 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 Age: 85 YR