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

Model Number	G38490
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
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: "following laser atherectomy and angioplasty - zilver ptx 6mmx120mm placed in distal left sfa - malfunctioning product (7mmx120mm ptx) stent was overlapped at proximal end of 6mmx120mm ptx stent.During deployment of 7x120, the proximal/last approx.10mm of stent deployment encountered large amount of resistance and deployment thumbwheel system no longer was deploying stent - last 10mm of stent fractured during attempt to pull back thumbwheel delivery system in effort to manually deploy stent.Following fracture - fractured 10mm of stent was snared/captured and pulled back into left external iliac in safe stenting area and re-lined/overlapped with a new larger bare metal self-expanding stent.An additional 7mmx120mm zilver ptx stent was placed inside fractured 7x120 to reline stent and at the at the proximal edge of new 7x120 stent, an additional 7mmx40mm ptx stent placed to cover occluded left sfa diseased vessel/complete stenting procedure.In total 6x120+7x120+7x40 along with fractured 7x120 were placed in patients sfa.
Event or Problem Description
As reported to customer relations: "following laser atherectomy and angioplasty - zilver ptx 6mmx120mm placed in distal left sfa - malfunctioning product (7mmx120mm ptx) stent was overlapped at proximal end of 6mmx120mm ptx stent.During deployment of 7x120, the proximal/last approx.10mm of stent deployment encountered large amount of resistance and deployment thumbwheel system no longer was deploying stent - last 10mm of stent fractured during attempt to pull back thumbwheel delivery system in effort to manually deploy stent.Following fracture - fractured 10mm of stent was snared/captured and pulled back into left external iliac in safe stenting area and re-lined/overlapped with a new larger bare metal self-expanding stent.An additional 7mmx120mm zilver ptx stent was placed inside fractured 7x120 to reline stent and at the at the proximal edge of new 7x120 stent, an additional 7mmx40mm ptx stent placed to cover occluded left sfa diseased vessel/complete stenting procedure.In total 6x120+7x120+7x40 along with fractured 7x120 were placed in patients (b)(6).
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.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: the zisv6-35-125-7-120-ptx device of lot number c1427146 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Document review: prior to distribution all zisv6 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 this 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 c1427146.It may be noted that the instructions for use states the following: a 0.035 inch (0.89mm) diameter wire guide should be used during tracking, deployment and removal in order to ensure adequate support of the system.If hydrophilic wire guides are used, they must be kept fully activated.¿ root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the use of a non-recommended wire guide combined with difficult patient anatomy.The use of a non-recommended wire guide could have contributed to insufficient device support which may have caused and/or contributed to resistance during advancement.Difficult patient anatomy could have caused or contributed to resistance during advancement and/or deployment.This resistance could have caused/contributed to higher deployment forces resulting in separation of the retraction wire from the stent retraction sheath (srs).Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.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.

• 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: 8042993
• Report Number: 3001845648-2018-00513
• Device Sequence Number: 11078212
• Product Code: NIU
• UDI-Device Identifier: 10827002384900
• UDI-Public: (01)10827002384900(17)190918(10)C1427146
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2019
• Device Model Number: G38490
• Device Catalogue Number: ZISV6-35-125-7-120-PTX
• Device Lot Number: C1427146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/09/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR