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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
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COOK IRELAND LTD ZILVER PTX 35 DRUG-ELUTING STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Model Number G38490
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
Us clearance number (5-10k): p100022/s014.(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As reported to customer relations: "dr.(b)(6) had the handle break during deployment.He was able to deploy the stent manually; however, he had to take the handle apart.There was no harm to the patient.Zisv6-35-125-7-120-ptx; 7/120; lot: c1429587; exp: 10/11/2019; i have the device for you if you¿d like it ¿ can you send me a replacement?".
 
Event Description
As reported to customer relations: "(b)(6) the handle break during deployment.He was able to deploy the stent manually however he had to take the handle apart.There was no harm to the patient.Zisv6-35-125-7-120-ptx; 7/120; lot: c1429587; exp: 10/11/2019; i have the device for you if you¿d like it, can you send me a replacement".
 
Manufacturer Narrative
Us clearance number (5-10k) : p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4) (importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4), importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
As reported to customer relations: "dr.Mena had the handle break during deployment.He was able to deploy the stent manually however he had to take the handle apart.There was no harm to the patient.Zisv6-35-125-7-120-ptx; 7/120; lot: c1429587; exp: 10/11/2019; i have the device for you if you¿d like it, can you send me a replacement".
 
Manufacturer Narrative
Us clearance number (5-10k) : p100022/s014.Cook ireland ltd (manufacturer) is submitting this report on behalf of (b)(4) (importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4), importer site establishment registration number: (b)(4).The zisv6-35-125-7-120-ptx device of lot number c1429587 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.Crinkling was observed on the stent retraction sheath (srs) and the retraction wire was separated from the srs on evaluation.The device was returned with the wire guide from the procedure in place.Prior to distribution zisv6-35-125-7-120-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 zisv6-35-125-7-120-ptx of lot number c1429587 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 c1429587.It should be noted that the instructions for use states the following: ¿if resistance is met during advancement of the delivery system, do not force passage.Remove the delivery system and replace with a new device.¿ ¿do not use excessive force to deploy the stent.If excessive resistance is felt when beginning deployment, remove the delivery system without deploying the stent and replace with a new device.¿ a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.From the information provided it is known that the patient exhibited a severely calcified anatomy.It is possible that difficult patient anatomy caused and/or contributed to resistance during advancement and/or deployment exerting excessive force on the outer sheath of the device.This may have resulted in high deployment forces causing the retraction wire to separate from the stent retraction sheath (srs).It is also known that approach used was contralateral and the bifurcation was ¿sharp¿.It is possible that the sharp bifurcation contributed to the resistance during advancement and/or deployment resulting in separation of the retraction wire from the srs.The 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.
 
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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 Key8469018
MDR Text Key140536214
Report Number3001845648-2019-00130
Device Sequence Number1
Product Code NIU
UDI-Device Identifier10827002384900
UDI-Public(01)10827002384900(17)191011(10)C1429587
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/29/2019
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 Expiration Date10/11/2019
Device Model NumberG38490
Device Catalogue NumberZISV6-35-125-7-120-PTX
Device Lot NumberC1429587
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2019
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/04/2019
Event Location Hospital
Initial Date Manufacturer Received 03/07/2019
Initial Date FDA Received04/01/2019
Supplement Dates Manufacturer Received03/07/2019
03/07/2019
Supplement Dates FDA Received04/29/2019
05/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age90 YR
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