MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION STENTS ADVANTA V12; STENT, ILIAC

Model Number 85339

Device Problems Difficult to Insert (1316); Difficult to Advance (2920); Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

During a procedure the surgeon used a 7fr cordis introducer, some resistance occurred and due to excessive force the stent became stuck in the introducer.Introducer was removed with the v12.The stent did not exit the introducer but the balloon did.Contrast agent mixture is unknown and not relevant as balloon was never inflated.

Event Description

Follow-up details from physician: on (b)(6) 2023 an attempt was made to advance an atrium stent via the li arm artery with a horizontal 7f shuttle lock (cook flexor 70 cm) into the internal iliac for the completion of an iliac side branch prosthesis (z-bis).In this case, the stent in the airlock detached from the balloon.The stent could only be recovered by removing the lock.The patient was not harmed by this.A new atrium stent was advanced via an 8 f flexor airlock; the aortic arch was somewhat elongated.May have led to the problem.With the exception of a vertebral catheter and a terumo wire, no other material was previously pushed over the airlock.The atrium stent was finally advanced via a 35.Er rose wire.Unfortunately, the airlock and the loosened stent have been disposed of, so that the material cannot be forwarded.

Manufacturer Narrative

Continued from d10: cook z-bis iliac side branch prosthesis, terumo wire investigation updated summary: on (b)(6) 2023, an atrium stent was attempted to be implanted via the left arm artery with a 7f shuttle lock (cook flexor 70 cm) in the a iliaca interna to complete an iliac side branch prosthesis (z-bis) to advance.The stent in the sluice came loose from the balloon.The stent could only be recovered by removing the sheath.The patient was not harmed by this.A new atrium stent was advanced through an 8f flexor sheath; the aortic arch was slightly elongated, which may have led to the problem.With the exception of a vertebral artery catheter and a terumo wire, no other materials had previously been pushed through the sheath.The atrium stent was ultimately advanced over a #35 rosette wire.Unfortunately, the sheath and the loosened stent have been disposed of, so the material cannot be passed on.The device in question is not being returned or the sheath used in the procedure.Without the device in question or more specific information regarding the case the complaint cannot be confirmed.As the product had been introduced through the brachial artery and down to the internal iliac artery and through a cook z-branch endograft and into the internal iliac artery it is likely that the tortuosity and or patient anatomy ¿(aortic arch was slightly elongated, which may have led to the problem)¿ was a key factor in the stent coming off the balloon within the introducer sheath.If the sheath had to navigate within a tight radius the sheath can lose its shape making passage of the catheter more difficult.No imaging from the procedure was provided within the complaint details.A review of the device history records shows that this product met all quality and performance requirements without any non-conformances.This includes the passage of 13 stent delivery systems through the 7fr introducer sheath as indicated on the product label and deployment of the stent without incident.There is no evidence that equipment, process, materials, or design was the cause of the complaint as all indications suggest the product met product requirements.There has been no other complaints associated with the affected lot of stent delivery systems from this complaint.A complaint history, and complaint trend review did not identify any related complaints or trends to specifically aid in the investigation.Based on the details of the complaint and the investigation results, the cause of the complaint is undetermined.Possible causes for the reported failure, which cannot be confirmed based on the details provided, include: the sheath was kinked or damaged during the procedure, making passage of the advanta v12 stent difficult.The anatomy of the patient was extremely tortuous, causing excess resistance during delivery.Variability in introducer sheath dimensions.A risk review found that the risk management documents for this product adequately address the reported defect.However, the actual occurrence rate for the hazardous situation/harm of ""stent dislodges from the catheter in the sheath/additional intervention required" over the 15 month trending period reviewed ((b)(4)) has exceeded the anticipated occurrence rate ((b)(4).) per the risk management file.A corrective and preventative action request has been initiated under cr 872463.Within the capa request, an initial investigation and risk assessment shall be performed and presented to the capa review board (crb) for determination if the event warrants further investigation or action under a capa.A labeling review was conducted.The ifu was found to provide adequate instructions for selection and use of accessory devices for the intended use.

Event Description

N/a.

Manufacturer Narrative

Additional information: section d9 & h6 the complaint details state that ¿the surgeon used a 7fr cordis introducer.Some resistance occurred and due to excessive force the stent became stuck in the introducer.The introducer was removed with the v12.The stent did not exit the introducer but the balloon did.¿ the device and sheath in question are not being returned and despite multiple attempts, none of the questions asked of the complainant were answered to aid in the investigation.Without the device in question or more specific information regarding the case the complaint cannot be confirmed.A review of the device history records shows that this product met all quality and performance requirements without any non-conformances.This includes the passage of 13 finished stent delivery systems (aql 1.0) through a 7fr introducer sheath as indicated on the product label and deployment of the stent without incident.It is important to note that the cordis 7fr brite tip introducer sheath is used for this testing.However, it is not known if this same sheath model was used in the complaint procedure.A review of the crimped stent diameter data contained within the dhr does not highlight any concerns and the data is in line with historical production values.A complaint history, and complaint trend review did not identify any related complaints or trends to specifically aid in the investigation.The capa review identified one historical capa for a similar confirmed event of device/sheath incompatibility, involving a different size device (10mm), and different introducer sheath (cook); however, it is possible that the root causes identified related to variability of introducer sheath dimensions, which are not manufactured by atrium medical corp., could be applicable to this complaint.However, without the device and details of the sheath in question, this cannot be confirmed.Based on the details of the complaint and the investigation results, the cause of the complaint is undetermined.There is no evidence that equipment, process, materials, or design was the cause of the complaint as all indications suggest the product met product requirements.Possible causes for the reported failure, which cannot be confirmed based on the details provided, include: ¿ the sheath was kinked or damaged during the procedure, making passage of the advanta v12 stent difficult.¿ the anatomy of the patient was extremely tortuous, causing excess resistance during delivery.¿ the physician could have inadvertently used a guiding catheter, instead of an introducer sheath.Guiding catheters have a smaller id than an introducer, as the labeled dimensions (7fr) are based on od, where as the same labeled dimensions (7fr) of an introducer are based on id.¿ variability in introducer sheath dimensions a labeling review was conducted.The instructions for use provide adequate instruction in regards to inspection of the device prior to use, for selection and use of accessory devices for the intended use, as well as to not force passage or removal of the device.Labeling review: intended use/indications (ifu aw011781-en) the advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.Renal approval includes 5mm, 6mm and 7mm diameter advanta v12 sizes.Warnings and cautions 6.Carefully inspect this device prior to use to verify that it has not been damaged in shipment and that the dimensions are suitable for the specific procedure 10.Always consult the product label to ensure a compatible sheath is selected for use.Do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.Forcing passage can result in damage to the stent or balloon catheter, stent dislodgment from the balloon, or separation of the catheter components.If using a 10mm device with a cook introducer sheath, it is recommended to size up to an 8 french sheath to minimize potential for resistance.Deployment 2.Confirm that the sheath selected is a compatible size with the selected advanta v12 balloon expandable covered stent identified on the product label.Note: increased resistance may be encountered when inserting a 10mm device through a 7 fr cook sheath; therefore, it is recommended to upsize to an 8 fr sheath when a cook sheath is used with a 10mm device.Complaint escalation determination: escalation is not required for this complaint.The complaint has not been confirmed and there is no indication of any nonconformance, nor a design, labeling, or manufacturing problem.The complaint is adequately covered in the risk management file, is operating within the approved risk profile, and no adverse trends have been detected.H3 other text : device not available for return.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 17208822
• MDR Text Key: 318020384
• Report Number: 3011175548-2023-00146
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2023

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 Model Number: 85339
• Device Catalogue Number: 85339
• Device Lot Number: 494043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 06/27/2023
• Supplement Dates Manufacturer Received: 07/25/2023; 07/28/2023
• Supplement Dates FDA Received: 08/01/2023; 08/15/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FR 70CM COOK FLEXOR SHEATH.; UNKNOWN.
• Patient Age: 73 YR
• Patient Sex: Male