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

Model Number G38489

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2019

Event Type  malfunction  

Manufacturer Narrative

510(k) number: p100022/s014.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

There are three files related to this incident.This file was created to capture the second device.Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿.As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system didn¿t move, seemed very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products.".

Event Description

There are three files related to this incident.This file was created to capture the second device.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.No adverse effects to the patient have been reported as occurring.As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system didn¿t moved seem very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products.".

Manufacturer Narrative

510(k) number: p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (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.

Manufacturer Narrative

510(k) number: 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.Two additional files have been opened in relation to this pr.For details of the other investigations please refer to pr (b)(4) and pr (b)(4).Device evaluation: the zisv6-35-125-7-100-ptx device of lot number c1472082 involved in this complaint was returned for evaluation without its original packaging.With the information provided, a physical examination and a document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 28th march 2019.Crinkling was observed on the stability sheath (ss) and the stent retraction sheath (srs).Part of the stent was missing and was not returned with the device.The handle was opened and the retraction wire was separated from the srs.It could not be confirmed where the missing piece of the stent was as it was not returned with the device.However, the sales rep has confirmed that only one stent (pr (b)(4) fractured in the patient.It is possible that the stent fractured on removal of the device form the patient and was discarded at the facility after the procedure.Document review: prior to distribution zisv6-35-125-7-100-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.A review of the manufacturing records for zisv6-35-125-7-100-ptx of lot number c1472082 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1472082.The instructions for use states the following: ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.From the information provided it is known that the patient exhibited tortuous and calcified anatomy.Difficult patient anatomy could have caused and/or contributed to high forces being exerted on the stent retraction sheath (srs) as the thumbwheel was rotated which could have caused and/or contributed to resistance or tightness as the thumbwheel was rotated resulting in the separation of the retraction wire from the srs.Separation of the retraction wire from the srs resulted in the partially deployed stent fracturing during device withdrawal.Summary: the complaint is confirmed as the failure was confirmed in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

There are three files related to this incident.This file was created to capture the second device.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture'.No adverse effects to the patient have been reported as occurring.As reported to customer relations, "products failed to deploy correctly.Deployment issue.Coaxial system did not moved seem very tight while scrolling back.While pulling first system out stent started coming out of catheter.Patient was ok.A stent was fracture and broke and left in patient, doctor angioplastied stent to wall in common femoral.No adverse effects.The second and third device felt tightness upon scrolling back, decided to remove device completely.Safely removed device, patient fine, no additional products.".

• 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: 8394691
• MDR Text Key: 138145935
• Report Number: 3001845648-2019-00090
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002384894
• UDI-Public: (01)10827002384894(17)191128(10)C1472082
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: G38489
• Device Catalogue Number: ZISV6-35-125-7-100-PTX
• Device Lot Number: C1472082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/07/2019
• Event Location: Hospital
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1