MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER VENA VENOUS SELF-EXPANDING STENT; NIO STENT, ILIAC

Model Number G57448

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problems Stacking Breaths (1593); High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422); Foreign Body Embolism (4439)

Event Date 04/27/2022

Event Type  Injury  

Event Description

Per patient's wife - he had to have open heart surgery at (b)(6) because the stent had migrated.He had problems with leg swelling before the stent was implanted.He had high blood pressure after the implant and the leg swelling became worse due to 60 mg of lasix.The device was implanted by (b)(6).The doctor thought the patient had a mass but it was the migrated stent.The stent had wrapped around a ventricle causing a minute leak.After explant, it was noticed that the filter never fully opened.Now, the patient was not feeling well/tired and has had anxiety after the explant.After cardiac physical therapy, they put the machine on him and he went into afib.He is not recovering as expected.Did any unintended section of the device remain inside the patient¿s body? not that was reported.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization due to this occurrence? yes.Did the patient require any additional procedures due to this occurrence? yes.If yes, please describe.Open heart surgery.Did the product cause or contribute to the need for additional procedures? yes.If yes, please specify additional procedures and provide details.Open heart surgery.Has the complainant reported any adverse effects on the patient due to this occurrence? yes.Has the complainant reported that the product caused or contributed to the adverse effects? yes.Please specify adverse effects and provide details.See event description.

Manufacturer Narrative

Pma/510(k) #: p200023.Common name - qan.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental correction) mdr is being submitted to amalgamate information from pr (b)(4) (3001845648-2022-00311) to this complaint pr (b)(4) (3001845648-2022-00595).Pr (b)(4) to be amalgamated into this file based on confirmation received on 25-aug-2022 that pr (b)(4) (logged by patients¿ wife) and pr 361799 (complaint from facility) are the same event.This report will update description of event, imdrf codes and upgrade to life threatening serious injury report as per clinical input from original pr (b)(4) (3001845648-2022-00311).Reported by the dm on behalf of the customer via email - a zilver vena 16x100 (g57448) that was placed in (b)(6) of 2020 migrated to the patient¿s right atrium and had to be removed via open heart surgery this past weekend.The patient had been experiencing symptoms for awhile but did not attest them to a potential stent migration until he had shortness of breath over the weekend and ended up in the bridgeport hospital ed where is was determined that there was a stent in his heart.After removal, the stent was seen to be very mangled and thus it is assumed that the stent had been migrated for awhile.The patient is doing well.The stent was placed by dr.(b)(6).Per patient's wife - he had to have open heart surgery at bridgeport hospital (c21635-0) because the stent had migrated.He had problems with leg swelling before the stent was implanted.He had high blood pressure after the implant and the leg swelling became worse due to 60 mg of lasix.The device was implanted by dr.Marsel huribal at the vascular experts (c43414-0).The doctor thought the patient had a mass but it was the migrated stent.The stent had wrapped around a ventricle causing a minute leak.After explant, it was noticed that the filter never fully opened.Now, the patient was not feeling well/tired and has had anxiety after the explant.After cardiac physical therapy, they put the machine on him and he went into afib.He is not recovering as expected.

Manufacturer Narrative

Pma/510(k) #: p200023.Section d: common name - qan.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Pma/510(k) #: p200023 section d: common name - qan investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to imaging review completed on 30-sep-2022.Reported by the dm on behalf of the customer via email - a zilver vena 16x100 (g57448) that was placed in (b)(6) 2020 migrated to the patient¿s right atrium and had to be removed via open heart surgery this past weekend.The patient had been experiencing symptoms for awhile but did not attest them to a potential stent migration until he had shortness of breath over the weekend and ended up in the bridgeport hospital ed where is was determined that there was a stent in his heart.After removal, the stent was seen to be very mangled and thus it is assumed that the stent had been migrated for awhile.The patient is doing well.The stent was placed by dr.Marcel huribal.Per patient's wife - her had to have open heart surgery at bridgeport hospital (c21635-0) because the stent had migrated.He had problems with leg swelling before the stent was implanted.He had high blood pressure after the implant and the leg swelling became worse due to 60 mg of lasix.The device was implanted by dr.Marsel huribal at the vascular experts (c43414-0).The doctor thought the patient had a mass but it was the migrated stent.The stent had wrapped around a ventricle causing a minute leak.After explant, it was noticed that the filter never fully opened.Now, the patient was not feeling well/tired and has had anxiety after the explant.After cardiac physical therapy, they put the machine on him and he went into afib.He is not recovering as expected.6.3.1.1 did any unintended section of the device remain inside the patient¿s body? -not that was reported ¿ if yes, please describe.6.3.1.2 was the patient hospitalized or was there prolonged hospitalization due to this occurrence? -yes 6.3.1.3 did the patient require any additional procedures due to this occurrence? -yes ¿ if yes, please describe.-open heart surgery 6.3.1.4 did the product cause or contribute to the need for additional procedures? -yes ¿ if yes, please specify additional procedures and provide details.-open heart surgery 6.3.1.5 has the complainant reported any adverse effects on the patient due to this occurrence? -yes 6.3.1.6 has the complainant reported that the product caused or contributed to the adverse effects? -yes ¿ please specify adverse effects and provide details.-see event description.

Manufacturer Narrative

Pma/510(k) #: p200023.Section d: common name - qan.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review: prior to distribution all devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data was not reviewed as the lot number is unknown.There is evidence to suggest that the customer did not follow the instructions for use as per image review.It should be noted that the instructions for use (ifu0091) states the following: ¿determine the proper stent size after complete diagnostic evaluation.Note: selection of inappropriate stent diameter and length based on lesion and vessel characteristics could lead to stent migration¿.Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer: the complaint of stent embolization from the left iliac veins into the heart cannot be confirmed because imaging of this event was not provided.Numerous risk factors for embolization were present.The stent was implanted in a normal left civ.This was not even a non-thrombotic iliac vein lesion (nivl) as no lesion was present.Less than one third (32.7mm) of the stent¿s length was fully opposed to vein wall and of that only 12.7mm was slightly oversized.Because the stent terminated in the cranial eiv, the mid eiv c-shape anchoring effect was not available.Vein dilating provocative manoeuvres such as valsalva, cough, or table tilt were either not provided or not performed.Even modest vein dilation with standing, sitting, coughing, valsalva, or any combination of these could have expanded the veins beyond the stent design diameter.Root cause review: a definitive root cause of user error - the physician/assistant selected the incorrect stent size after diagnostic evaluation which lead to the stent migrating inside the patient post procedure, was determined from the available information.Summary: this pr was raised as a patient had a stent implanted and it migrated to his heart post implantation.The patient had to have open heart surgery to remove this device.From the image review, it was found that numerous risk factors for embolization were present and the root cause was determined to be user error ¿ the physician/assistants selected the incorrect stent size after diagnostic evaluation which lead to the stent migrating inside the patient post procedure.The complaint of stent embolization from the left iliac veins into the heart cannot be confirmed because imaging of this event was not provided however, the complaint is confirmed based on the failure verified in the investigation.The image review has indicated that numerous risk factors for embolization were present.This may have caused or contributed to stent migration according to the initial reporter, the patient experienced shortness of breath and had to undergo open heart surgery to remove this stent.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 22feb2023.

• Brand Name: ZILVER VENA VENOUS SELF-EXPANDING STENT
• Type of Device: NIO STENT, ILIAC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND; holstein campus kiel; arnold- keller str- 3; limerick
• Manufacturer Contact: sinead o'leary ; holstein campus kiel; arnold- keller str- 3; limerick
• MDR Report Key: 15320015
• MDR Text Key: 298883765
• Report Number: 3001845648-2022-00595
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 10827002574486
• UDI-Public: (01)10827002574486(17)231016(10)C1768452
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2023
• Device Model Number: G57448
• Device Catalogue Number: ZVT7-35-80-16-100
• Device Lot Number: C1768452
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2022
• Event Location: Hospital
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male