Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOK IRELAND LTD UNKNOWN; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING Back to Search Results
Catalog Number UNKNOWN
Device Problem Obstruction of Flow (2423)
Patient Problem Occlusion (1984)
Event Date 05/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
On (b)(6) 2018 - (b)(6) -2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.This mdr is related to mdr reports; 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00515, 3001845648-2018-00516, 3001845648-2018-00518.
 
Manufacturer Narrative
510 (k) number: p100022/s014.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).This specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore 510(k) number provided is of the device considered "similar" 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)(6).(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
On (b)(6) 2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).Reporting based on surgical intervention (re-intervention and additional stent placement) carried out due to the occurrence of restenosis after unknown stent (assumed zisv6-ptx) implantation.This mdr is related to mdr reports: 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00515, 3001845648-2018-00516, and 3001845648-2018-00518.
 
Manufacturer Narrative
510 (k) number: p100022/s014.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).This specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore 510(k) number provided is of the device considered "similar" 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.Device evaluation: the unknown 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 rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all zilver ptx devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is no evidence to suggest that the customer did not follow the instructions for use.However, it should be noted that restenosis of the stented artery is listed as a known potential adverse event within the ifu.Image review: a number of attempts have been made to obtain imaging for review.However, at the time of the investigation, this was not available.The investigation will be updated when the images are received by cook ireland.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause for restenosis could be attributed to the patient¿s pre-existing conditions.From the information provided, it is known that the patient has a history of hypertension, hypercholesterolemia and is a current smoker.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, an additional stent was placed as a result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
On (b)(6) 2018 -(b)(6) 2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018 - (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).Reporting based on surgical intervention (re-intervention and additional stent placement) carried out due to the occurrence of restenosis after unknown stent (assumed zisv6-ptx) implantation.This mdr is related to mdr reports; 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00515, 3001845648-2018-00516, 3001845648-2018-00518.
 
Manufacturer Narrative
510 (k) number: p100022/s014.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).This specific zilver ptx tw device is currently not cleared / approved in the us.However, this device is considered 'similar' to other zilver® ptx® drug eluting peripheral stent devices currently marketed in the us therefore 510(k) number provided is of the device considered "similar" 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: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
 
Event Description
On (b)(6) 2018 - (b)(6) 2018, the patient was hospitalized where an occlusion was discovered in the study lesion and in the non-study leg.On (b)(6) 2018 - (b)(6) 2018, these were both treated with a stent placement and an angioplasty.This was considered probably related to the device.Adopting a cautious approach, it is assumed that the device was a similar device as used in this patient previously (i.E.Zisv6-ptx ).Reporting based on surgical intervention (re-intervention and additional stent placement) carried out due to the occurrence of restenosis after unknown stent (assumed zisv6-ptx) implantation.This mdr is related to mdr reports; 3001845648-2018-00044, 3001845648-2018-00045, 3001845648-2018-00519, 3001845648-2018-00514, 3001845648-2018-00515, 3001845648-2018-00516, 3001845648-2018-00518.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN
Type of Device
NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
MDR Report Key8046495
MDR Text Key126509511
Report Number3001845648-2018-00517
Device Sequence Number1
Product Code NIU
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,Followup
Report Date 01/02/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received11/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/17/2018
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/07/2018
Event Location Hospital
Date Manufacturer Received10/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight66
-
-