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

Catalog Number UNKNOWN

Device Problems Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(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.

Event Description

As reported to customer relations: date of implant ¿ (b)(6) 2017; negative reaction ¿ stent clotted off within 4 months; outcome - had a secondary procedure to open the stent, but she believes that it is clotted off again because she is experiencing similar symptoms as before.

Manufacturer Narrative

510(k) number: n/a.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: ed sutkowski, cook medical incorporated (cmi), 1025 acuff road, p.O box 4195, bloomington, indiana, 47402-4195, importer site establishment registration number: 3005580113.Problem statement "as reported to customer relations: date of implant ¿ december 2017 negative reaction ¿ stent clotted off within 4 months outcome - had a secondary procedure to open the stent, but she believes that it is clotted off again because she is experiencing similar symptoms as before." device evaluation two complaint files pr 239451 and pr 238456 were opened for this complaint.This was due to the patient's belief that the stent clotted off for the second time after she experienced similar symptoms again.We have been unable to obtain further information from the patient regarding this event.The zilver ptx device of unknown rpn and unknown lot number involved in this complaint was implanted in the patient, and was not available for evaluation.With the information provided, a limited was conducted.It is known that the patient was going to meet with another physician for a second opinion.At the time of the investigation, no further information was available.The investigation will be updated should any more information be made available to cook ireland in the future.The complaint is not confirmed as there is no failure mode to assess based on the information available at this time.Stent ¿clotting¿ could refer to a number of different defects for example thrombosis, restenosis or collapsing due to stent fatigue.Should any additional information be received in the future the investigation will be updated and the risk may be assessed.As the circumstances of use cannot be replicated in a laboratory environment and as there was a lack of information available for this complaint, a definitive root cause cannot be determined.There is no evidence to suggest that the customer did not follow the instructions for use.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 as per finished product q.C.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, the patient had a secondary procedure to open the stent but believed the stent clotted off again as she experienced similar symptoms.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations: date of implant ¿ (b)(6) 2017.Negative reaction ¿ stent clotted off within 4 months.Outcome - had a secondary procedure to open the stent, but she believes that it is clotted off again because she is experiencing similar symptoms as before.

Manufacturer Narrative

Pma/510(k) #: p100022.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.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.

Event Description

Additional information received, file re-opened, investigation is ongoing and will be updated to include the investigation conclusions.As reported to customer relations: date of implant ¿ (b)(6) 2017.Negative reaction ¿ stent clotted off within 4 months.Outcome - had a secondary procedure to open the stent, but she believes that it is clotted off again because she is experiencing similar symptoms as before.

Manufacturer Narrative

Pma/510(k) #: p100022.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.Additional information received from the patient.This event was originally reported based on a cautious approach that an intervention may have been required.With the full description of events, there was no intervention in this event.

Event Description

Additional information received, this report is being submitted as a cancellation report.As reported to customer relations: date of implant ¿ (b)(6) 2017.Negative reaction ¿ stent clotted off within 4 months.Outcome - had a secondary procedure to open the stent, but she believes that it is clotted off again because she is experiencing similar symptoms as before.

• 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
• MDR Report Key: 7905348
• MDR Text Key: 121585264
• Report Number: 3001845648-2018-00449
• 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,Followup
• Report Date: 07/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/07/2018
• Event Location: Hospital
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention