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

Catalog Number ZISV6-35-125-7-40-PTX

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # = p100022/s014.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

This pr addresses the 2nd stent.For details of the 1st stent please see (b)(4).Customer (b)(6).Physician: dr.(b)(6).Dos: (b)(6) 2018.Patient info: unavailable, i was made aware of this event on (b)(6) 2018.Type of procedure: sfa stent.Products: g38486 lot: unavailable.Products: g38486 lot: unavailable.Both stents were deployed in the patient and unavailable for return.Products do not need to be replaced.Acknowledgment letter and follow up to be sent to dr.(b)(6).Event: through a short 11cm sheath and over an amplatz wire, physician attempted to deploy a 7x40 zilver ptx g38486 on the proximal sfa up to the origin of the sfa in an antegrade fashion, the area to be stented was not calcified and not tortuous.Upon deployment, stent jumped about 2cm below the distal markers ((b)(4)), where it was supposed to land.Since it didn¿t land where he needed it to, physician tried to deploy another g38486 up to the sfa origin again, this time physician held the distal part of the delivery sheath hoping that will stabilize the stent deployment, however the second g38486 compressed and superimposed ((b)(4)) with the first g38486, it did not land where he needed it to (did not land at the origin of the sfa).Physician did not attempt anything else after.Patient is okay and did not need any additional procedures.".

Event Description

This pr addresses the 2nd stent.For details of the 1st stent please see (b)(4).Customer (b)(6).Physician: dr.(b)(6).Dos: (b)(6) 2018.Patient info: unavailable.I was made aware of this s event on 11/15/18.Type of procedure: sfa stent.Products: g38486 lot: unavailable.Products: g38486 lot: unavailable.Both stents were deployed in the patient and unavailable for return.Products do not need to be replaced.Images attached.Acknowledgment letter and follow up to be sent to dr.(b)(6): (b)(6).Event: through a short 11cm sheath and over an amplatz wire, physician attempted to deploy a 7x40 zilver ptx g38486 on the proximal sfa up to the origin of the sfa in an antegrade fashion, the area to be stented was not calcified and not tortuous.Upon deployment, stent jumped about 2cm below the distal markers ((b)(4)), where it was supposed to land.Since it didn¿t land where he needed it to, physician tried to deploy another g38486 up to the sfa origin again, this time physician held the distal part of the delivery sheath hoping that will stabilize the stent deployment, however the second g38486 compressed and superimposed ((b)(4)) with the first g38486, it did not land where he needed it to (did not land at the origin of the sfa).Physician did not attempt anything else after.Patient is okay and did not need any additional procedures.".

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).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.

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 (b)(4).Importer site establishment registration number: (b)(4).Device evaluation there are two additional files related to this complaint.For details of the other investigations refer to pr 246487 and pr 247660.The zisv6-35-125-7-40-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.Document review as the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.Prior to distribution zisv6-35-125-7-40-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.It may be noted that the instructions for use states the following: ¿note: ensure the distal end of the stability sheath is inside the access sheath.¿ image review 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.The antegrade left sided access is confirmed.The images and complaint report are consistent with stent mal-deployment caused by stent jumping on deployment and concertinaed deployment.However, the dimensions in the complaint report cannot be confirmed.2.The short antegrade access, the choice of stents, and the proximal landing zone created three unusual conditions.First, because the stents were short, deployment happened so quickly that remediation was not possible.Second, the stability sheath was outside the access sheath during each deployment.Third, the inherently steep common femoral artery (cfa) entry angle of antegrade access increased friction between the retraction and access sheath.3.Under these conditions, as the retraction ribbon was retracted, the ribbon and inner dilator built up tension along the meter-long delivery system outside the patient.When the stored tension overcame the friction between the stent and the retraction sheath, the stent and inner dilator abruptly advanced as the stent began to deploy.Normal deployment involves a steadied handle, often resting on the patient, with the catheter straight to slightly bowed but not under tension.In this case, the system needed to be straight, taut, and elevated so the handle could be retracted as the stent deployed.After the stent jumped forward, the operator reflexively retracted the handle allowing the stent to deploy to its design length rather than in a concertinaed fashion.4.During deployment of the second stent, the operator held the retraction sheath at the access sheath.With the retraction sheath fixed, winding the retraction ribbon advanced the stent and inner dilator.This deployed the stent in a concertinaed fashion.It is impossible to deploy the stent normally holding the retraction sheath at the access sheath.Root cause review a definitive root cause of tension along the retraction ribbon and inner dilator as a result of the user error situation whereby the stability sheath was not inside the access sheath and the steep cfa entry angle of antegrade access were identified from the available information.As the retraction sheath was fixed (held at the access sheath) and the thumbwheel was rotated, the stent and inner dilator were advanced.This resulted in the stent being deployed concertained.Summary complaint is confirmed as the failure was verified in the image(s).The stent was deployed concertained as a result of user error.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

This pr addresses the 2nd stent.For details of the 1st stent please see pr 246542.· customer (b)(4).· physician: (b)(6).· dos: (b)(6) 2018.Patient info: unavailable.I wamade aware of this s event on (b)(6) 2018.Type of procedure: sfa stent.· products: g38486 lot: unavailable, · products: g38486 lot: unavailable, · both stents were deployed in the patient and unavailable for return.· products do not need to be replaced.Images attached.· acknowledgment letter and follow up to be sent to (b)(6).· event: through a short 11cm sheath and over an amplatz wire, physician attempted to deploy a 7x40 zilver ptx g38486 on the proximal sfa up to the origin of the sfa in an antegrade fashion, the area to be stented was not calcified and not tortuous.Upon deployment, stent jumped about 2cm below the distal markers (pr246487), where it was supposed to land.Since it didn¿t land where he needed it to, physician tried to deploy another g38486 up to the sfa origin again, this time physician held the distal part of the delivery sheath hoping that will stabilize the stent deployment, however the second g38486 compressed and superimposed (pr246489) with the first g38486, it did not land where he needed it to (did not land at the origin of the sfa).Physician did not attempt anything else after.Patient is okay and did not need any additional procedures.".

• 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: 8160346
• MDR Text Key: 131416438
• Report Number: 3001845648-2018-00580
• 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: 01/11/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-7-40-PTX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 11/15/2018; 11/15/2018
• Supplement Dates FDA Received: 01/10/2019; 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1