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

Catalog Number UNKNOWN

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Occlusion (1984)

Event Date 06/29/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # : pi00022/s014.(b)(4).Information pertaining to section as follows: (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Report is being submitted due to serious injury and under the precedence of "stent fracture"."the patient presented with leg pain.An angiogram was performed and it was determined that the stent had fractured, causing an occlusion in the popliteal.The physician went through the fractured stent and deployed another stent.This treatment did restore blood flow.".

Manufacturer Narrative

(b)(4).Exemption number: e2016031.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations "the patient presented with leg pain.An angiogram was performed and it was determined that the stent had fractured, causing an occlusion in the popliteal.The physician went through the fractured stent and deployed another stent.This treatment did restore blood flow.".

Manufacturer Narrative

510(k) number: n/a 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.Device evaluation: the unknown 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.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: impression: 1.Although a pa (popliteal artery) stent with stretching and a fracture centered at the right femoral condyle level and pa occlusion is confirmed, the image quality is insufficient to determine whether the fracture was type ill, iv, or v.2.Popliteal artery tortuosity indicates the pa artery also was elongated.Consequently, the stent was subjected not only to knee flexion but also artery lengthening and twisting with flexion.The complaint is confirmed as the failure was verified in the images.A popliteal artery (pa) stent with stretching and fracture and a pa occlusion were confirmed in the image review.However, due to poor image quality the type of fracture could not be identified.From the image review, a possible root cause for this complaint could include tortuous patient anatomy and fatiguing of the stent due to knee flexion.As per the image review ¿popliteal artery tortuosity indicates the pa artery also was elongated.Consequently, the stent was subjected not only to knee flexion but also artery lengthening and twisting with flexion¿.The tortuous patient anatomy combined with the impact of knee flexion on the stent could have caused or contributed to the stent fracture.However, as the device is not available, the images have not yet been reviewed and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.It may be noted that stent strut fracture is listed as a possible adverse effect in the instructions for use.It can be noted that ¿stent strut fracture¿ is listed as a potential adverse event within the instructions for use.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 all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per finished product q.C.Summary the complaint is confirmed as the failure was verified in the images.A popliteal artery (pa) stent with stretching and fracture and a pa occlusion were confirmed in the image review.However, due to poor image quality the type of fracture could not be identified.The risk associated with this complaint is risk category iii/low.According to the initial reporter, the patient required an additional stent to treat the occlusion of the popliteal artery.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations "the patient presented with leg pain.An angiogram was performed and it was determined that the stent had fractured, causing an occlusion in the popliteal.The physician went through the fractured stent and deployed another stent.This treatment did restore blood flow.".

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7721660
• MDR Text Key: 115062670
• Report Number: 3001845648-2018-00337
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/29/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 07/02/2018
• Supplement Dates FDA Received: 08/24/2018; 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR