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 Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Occlusion (1984); Pain (1994); Thrombus (2101)

Event Type  Injury  

Manufacturer Narrative

The exact rpn is unknown, however from the complaint description we know the device is a zisv6-xxx-ptx, 510(k) number: 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: 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

The exact rpn is unknown, however from the complaint description we know the device is a zisv6-xxx-ptx, 510(k) number: p100022/s014.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)(6).(b)(4).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 (b)(4) 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: 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.

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.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

Follow up report is being submitted due to the receipt of additional information.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.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #: p100022 cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: (b)(4).Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).Device evaluation it should be noted that there are four other investigations related to this file.For details of the other investigations please refer to pr 239451, pr 267674, pr 268014 and pr 268720.The zisv6 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.Lab evaluation ¿ n/a 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 zisv6 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.There is no evidence to suggest that the customer did not follow the instructions for use.Image review ¿ n/a root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.From the information provided directly by the customer it is known that the stents were implanted to treat peripheral arterial disease (pad).It is possible that this caused and/or contributed to the stents ¿clogging¿.Based on the information provided to date a definitive failure mode cannot be assigned for this complaint as it is not known what is meant by ¿the stents were clogged¿.This could be referring to a number of potential failures including restenosis or thrombosis.Summary the complaint is confirmed based on customer testimony.However, as a failure mode cannot be established from the information provided, the risk for this file will not be assessed at this time.According to the initial reporter, the patient was admitted to hospital in an attempt to open the stents with ¿clot busters¿ and a ¿balloon¿ as a result of this event.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 ¿ 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.

Manufacturer Narrative

Pma/510(k) #: p100022.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Additional correspondence received and the investigation has been updated to reflect this.

Event Description

16-dec-19: additional information received reporting stenosis between both stents.Clinical input confirms this is not device related.

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

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: on (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.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15.[secondary procedure to address the first clotting event; second clotting event has no additional details].

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.Further information from dr.Carlos mena, yale new haven (b)(6) 2018 - patient presented with resting leg pain.An angiogram revealed thrombus in two sfa stents.Stents were not overlapping but had a gap between them.Dr.Mean performed a lysis procedure with good results.Both stents were patent.However, there was still high grade stenosis between the stents.Physician performed angioplasty with coda balloon with good result.(b)(6) 2019 - patient presented again with more pain.An angiogram showed high grade stenosis in the gap between stents, very localized.Performed angioplasty with good result.(b)(6) 2019 - saw patient in clinic and stents were still open.Patient had no pre-existing conditions that would have contributed to thrombus.(b)(6) 2019 smt (b)(6) 2019: additional information received reporting stenosis between both stents.Clinical input confirms this is not device related.

Manufacturer Narrative

Device evaluation it should be noted that there are four other investigations related to this file.For details of the other investigations please refer to pr 239451, pr 267674, pr 268014 and pr 268720.A number of requests have been made for additional information and medical imaging.However, at the time of the investigation, this was unavailable for review.Should any additional information or medical imaging be made available to cirl this file, along with the above mentioned related files, will be re-opened and updated accordingly.This file investigates the event of stent thrombosis noted to have occurred between the index procedure on (b)(6) 2017 and (b)(6) 2018 when the patient was admitted into hospital as a result of this event.The zisv6 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 zisv6 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.It should be noted that arterial thrombosis is listed as a known potential adverse event within the instructions for use (ifu0118-5).There is no evidence to suggest that the customer did not follow the ifu.Root cause review a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing conditions.From the information provided directly by the patient it is known that the stents were implanted to treat peripheral arterial disease (pad).It is possible that this caused and/or contributed to the event of thrombosis.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient was admitted to hospital in an attempt to open the stents with ¿clot busters¿ and a ¿balloon¿ (angioplasty) as a result of this event.The attempt to reopen the stents was unsuccessful.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 7884169
• MDR Text Key: 120574258
• Report Number: 3001845648-2018-00431
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P100022
• 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,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/20/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 08/28/2018; 08/28/2018; 08/28/2018; 08/28/2018; 08/28/2018; 08/28/2018; 08/28/2018
• Supplement Dates FDA Received: 10/16/2018; 07/04/2019; 08/01/2019; 11/13/2019; 12/11/2019; 01/08/2020; 02/05/2020; 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention