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

Catalog Number ZISV6-35-125-7.0-120-PTX

Device Problem Delivery System Failure (2905)

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

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

Pma #p100022/s014.(b)(4).Problem statement: "stent placement with three zilver stents in the right sfa (superficial femoral artery) by contralateral approach from the left fa (femoral artery) was conducted on a patient.Prepared stent: zilver ptx 7 mm 12 cm x 2 pcs + 8 mm 8 cm x 1 pc.Abbott's wire guide "command 0.014 inch 300 cm" was used with the first and second stents (zilver ptx 7 mm 12 cm x 2 pcs).The first stent was placed with no problem, but the event occurred during deployment of the second stent (zisv6-35-125-7.0-120-ptx/ c1455462 x1pc) as follows.When approximately 1 cm of the second stent was still inside the sheath during an attempt of deployment in the middle of the right sfa by rotating the thumbwheel, the outer sheath stopped being withdrawn although the user kept rotating the thumbwheel.Therefore, he disassembled the handle of the ptx and pulled a part of the outer sheath manually.Then, the stent could be fully deployed successfully without elongation or shortening.Then, the wire guide was changed with another 0.014 inch one and the procedure was completed after placing the third stent.There have been no adverse effects to the patient reported." device evaluation: the zisv6-35-125-7.0-120-ptx device involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, the complaint device was advanced over a 0.014¿ diameter, abbot command wire guide.The physician made the following additional statements: ¿i might have removed the device from the packaging tray roughly, so i wonder if the rough device removal might have contributed to the event.¿ "i feel that the ticking noise when rotating the thumbwheel has changed from "heavy" one to "light" one recently." sustaining engineering and product development were contacted, and confirmed that there have been no changes to the design of the device that could impact the noise of the thumbwheel mechanism.The customer was contacted to request additional information.The investigation will be updated once the information has been provided.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include a difficult patient anatomy, bends or kinks on the device or the use of a non-recommended wire guide.A calcified anatomy could have created resistance during deployment, and the non-recommended wire guide could have provided insufficient support during advancement and deployment.In addition, the physician reported that the device was handled roughly, which could have kinked or bent the delivery system.These factors could have caused or contributed to the thumbwheel malfunctioning, and the inability to fully deploy the stent.However, as the information has not yet been provided, the complaint device is not available and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.It can be noted that as per the product insert:¿to ensure adequate support of the system, introduce a 0.89 mm (0.035 inch) guide wire through the sheath across the distal segment of the target lesion.¿ and "under fluoroscopy, advance the delivery system over a 0.89-mm (0.035-inch) guide wire through the sheath until the distal end stent marker goes beyond the target lesion" document review: prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.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 this lot number.Summary: there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.The risk will be assessed for this complaint once the additional information is provided.When the risk has been assessed the investigation will be updated with the risk details.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

Initial mdr is being submitted based on the device malfunction precedence: ¿thumbwheel malfunctions during deployment".Stent placement with three zilver stents in the right sfa by contralateral approach from the left fa was conducted on a patient.Prepared stent: zilver ptx 7 mm 12 cm x 2 pcs + 8 mm 8 cm x1pc.Abbott's wire guide "command 0.014 inch 300 cm" was used with the first and second stents (zilver ptx 7 mm 12 cm x 2 pcs).The first stent was placed with no problem, but the event occurred during deployment of the second stent (zisv6-35-125-7.0-120-ptx/ c1455462 x1pc) as follows.When approximately 1 cm of the second stent was still inside the sheath during an attempt of deployment in the middle of the right sfa by rotating the thumbwheel, the outer sheath stopped being withdrawn although the user kept rotating the thumbwheel.Therefore, he disassembled the handle of the ptx and pulled a part of the outer sheath manually.Then, the stent could be fully deployed successfully without elongation or shortening.Then, the wire guide was changed with another 0.014 inch one and the procedure was completed after placing the third stent.There have been no adverse effects to the patient reported.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7637654
• MDR Text Key: 113038414
• Report Number: 3001845648-2018-00286
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352909
• UDI-Public: (01)10827002352909(17)191130(10)C1455462
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: ZISV6-35-125-7.0-120-PTX
• Device Lot Number: C1455462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/22/2018
• Event Location: Hospital
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1