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

Catalog Number ZFV6-125-6-8.0

Device Problems Structural Problem (2506); Activation, Positioning or Separation Problem (2906)

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

Event Date 04/24/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr.(b)(6) deploy the stent following the ifu.The stent has deployed about 1/3, than the sheath of the deploy system suddenly departed from the black handle.However, dr.(b)(6) keep deploying the stent by pull back the sheath.The stent was elongated during the middle part but remain normal within the proximal and distal part.

Event Description

Imaging review: "stent implantation stretched to 93.5mm is confirmed.The deployment sequence is consistent with the complaint of the retraction sheath and handle separation.The separation was the result of friction between retraction sheath and inner catheter.The onset of friction was evident in stretch between the first 14mm and 29mm of stent deployment.(figure 1) at 29mm, the sheath and handle separated.Friction continued to retract the inner catheter through the entire deployment as the retraction sheath was manually pulled backed.The normal appearance of proximal stent was product of stent retraction and not inner catheter stabilization".

Manufacturer Narrative

Pma/510(k) #: p050017/s006.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Dr.(b)(6) deploy the stent following the ifu.The stent has deployed about 1/3, than the sheath of the deploy system suddenly departed from the black handle.However, dr.(b)(6) keep deploying the stent by pull back the sheath.The stent was elongated during the middle part but remain normal within the proximal and distal part.Dr.(b)(6) deploy the stent following the ifu.The stent has deployed about 1/3, than the sheath of the deploy system suddenly departed from the black handle.However, dr.(b)(6) keep deploying the stent by pull back the sheath.The stent was elongated during the middle part but remain normal within the proximal and distal part.Imaging reviewed on (b)(6) 2020: "stent implantation stretched to 93.5mm is confirmed.The deployment sequence is consistent with the complaint of the retraction sheath and handle separation.The separation was the result of friction between retraction sheath and inner catheter.The onset of friction was evident in stretch between the first 14mm and 29mm of stent deployment.(figure 1) at 29mm, the sheath and handle separated.Friction continued to retract the inner catheter through the entire deployment as the retraction sheath was manually pulled backed.The normal appearance of proximal stent was product of stent retraction and not inner catheter stabilization".

Manufacturer Narrative

Pma/510(k)#: p050017/s006.Device evaluation: the zfv6-125-6-8.0 device of lot number: c1384816 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 09jun2020.Handle flexor separation was noted.Document review: prior to distribution zfv6-125-6-8.0 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 relevant manufacturing records (b)(4) 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: c1384816.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0058-2).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 (ref: (b)(4) imaging review ver1'): impression: stent implantation stretched to 93.5mm is confirmed.The deployment sequence is consistent with the complaint of the retraction sheath and handle separation.The separation was the result of friction between retraction sheath and inner catheter.The onset of friction was evident in stretch between the first 14mm and 29mm of stent deployment.(figure 1) at 29mm, the sheath and handle separated.Friction continued to retract the inner catheter through the entire deployment as the retraction sheath was manually pulled backed.The normal appearance of proximal stent was product of stent retraction and not inner catheter stabilization.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 excessive pressure on the flexor during deployment as a result of patient anatomy being calcified.It is possible that difficult patient anatomy caused and/or contributed to high deployment forces during attempted deployment resulting in the flexor separating from the handle.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.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10086194
• MDR Text Key: 192030644
• Report Number: 3001845648-2020-00310
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002519265
• UDI-Public: (01)10827002519265(17)200808(10)C1384816
• 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: 09/07/2020

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 Expiration Date: 08/08/2020
• Device Catalogue Number: ZFV6-125-6-8.0
• Device Lot Number: C1384816
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/24/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/26/2020
• Supplement Dates Manufacturer Received: 04/27/2020; 04/27/2020
• Supplement Dates FDA Received: 07/02/2020; 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR