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

Model Number	G38481
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k) #: 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.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations: "when they went to deploy the stent the thumbwheel deployed about 1-2cm and then the thumbwheel began to turn freely without deploying.A piece of wire is also sticking out of the thumbwheel; it is not known at what point the wire came out, but the wire seemed to be turning with the wheel.Device was removed and another of the same gpn was used to complete the procedure successfully." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿ and "stent retraction wire separates".No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Pma/510(k)#: 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).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations: "when they went to deploy the stent the thumbwheel deployed about 1-2cm and then the thumbwheel began to turn freely without deploying.A piece of wire is also sticking out of the thumbwheel; it is not known at what point the wire came out, but the wire seemed to be turning with the wheel.Device was removed and another of the same gpn was used to complete the procedure successfully." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿ and "stent retraction wire separates".No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
Pma/510(k)#: 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).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.Device evaluation the zisv6-35-125-6-100-ptx device of lot number: c1475927 involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 20 june 2019.On evaluation of the device, the retraction wire was sticking out from the handle at the thumbwheel, crinkling was observed on the stent retraction sheath (srs), the stent was partially deployed and damaged and a piece of it was missing.The device would not flush but was wired with no problems.The thumbwheel rotated freely and the retraction wire was separated from the srs when the handle was opened in the laboratory.Document review prior to distribution zisv6-35-125-6-100-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 zisv6-35-125-6-100-ptx of lot number: c1475927 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: c1475927.It should be noted that the instructions for use states the following: ¿precautions a 0.89 mm (0.035 inch) wire guide should be used during tracking, deployment, and removal to ensure adequate support of the system.If hydrophilic wire guides are used, they must be kept fully activated.¿ there is evidence to suggest that the customer did not follow the ifu.Image review: n/a.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the use of a non-recommended wire guide with the device.From the information provided it is known that a 0.014¿ wire guide was used with the device and the patient¿s anatomy was probably tortuous or calcified.It is possible that the use of a non-recommended wire guide resulted in insufficient device support during advancement causing and/or contributing to resistance.A difficult patient anatomy would also have contributed to resistance during advancement resulting in increased deployment forces on the device.It is possible that the resistance and higher deployment forces during advancement and/or deployment caused and/or contributed to the retraction wire separating from the srs as the stent was being deployed.This would have resulted in the partial stent deployment as observed on return of the device.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
As reported to customer relations: "when they went to deploy the stent the thumbwheel deployed about 1-2cm and then the thumbwheel began to turn freely without deploying.A piece of wire is also sticking out of the thumbwheel; it is not known at what point the wire came out, but the wire seemed to be turning with the wheel.Device was removed and another of the same gpn was used to complete the procedure successfully." fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿thumbwheel malfunctions during deployment¿ and "stent retraction wire separates".No adverse effects to the patient have been reported as occurring.

• Brand Name: ZILVER PTX 35 DRUG-ELUTING STENT
• Common Device Name: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8715405
• Report Number: 3001845648-2019-00270
• Device Sequence Number: 13914572
• Product Code: NIU
• UDI-Device Identifier: 10827002384818
• UDI-Public: (01)10827002384818(17)191116(10)C1475927
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: G38481
• Device Catalogue Number: ZISV6-35-125-6-100-PTX
• Device Lot Number: C1475927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/24/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 05/28/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/19/2019; 08/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1