MAUDE Adverse Event Report: CORDIS CORPORATION TRAPEASE W/CSI INTRO KIT 55CM; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number 466P306A

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 08/30/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17899773 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after placement of a 55cm trapease vena cava filter with catheter sheath introducer (csi) kit inside of the patient, the filter could not be released and was under-expanded.As a result, a large unknown csi was inserted over an unknown guidewire to grasp the filter and remove it, and a non-cordis long-term retrievable filter of an unknown size was used as a replacement.The procedure continued with thrombectomy via a non-cordis mechanical thrombectomy system in the left iliac and femoral veins.There was no reported injury to the patient and the event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.This was during a planned filter placement procedure for a patient who was previously admitted to the hospital due to swelling of the left lower limb.It was reported that the patient had a large amount of thrombus within their iliofemoral vein which was observed via digital subtraction angiography (dsa).Anticoagulation therapy was given and there were no contraindications for anticoagulants.The ivc was reported as straight and measured 25cm in diameter.The device was stored and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.There was no difficulty while advancing the deployment sheath to the deployment target.There were no acute bends, tortuosity, calcification, thrombosis, or stenosis at the target site.It was verified under fluoroscopy that no parts of the filter were within a side vessel.There was no reported separation of the device.The device will not be returned.It was reported that the thermal indicator was activated.Information regarding the thermal activator is still pending.

Manufacturer Narrative

Complaint conclusion: as reported, after placement of a 55cm trapease vena cava filter with catheter sheath introducer (csi) kit inside of the patient, the filter could not be released and was under-expanded.As a result, an 11f non-cordis csi was inserted over an unknown guidewire to grasp the filter and remove it, and a non-cordis long-term retrievable filter of an unknown size was used as a replacement.The procedure continued with thrombectomy via a non-cordis mechanical thrombectomy system in the left iliac and femoral veins.There was no reported injury to the patient and the event did not cause a condition that requires hospitalization or significant prolongation of existing hospitalization.This was during a planned filter placement procedure for a patient who was previously admitted to the hospital due to swelling of the left lower limb.It was reported that the patient had a large amount of thrombus within their iliofemoral vein which was observed via digital subtraction angiography (dsa).Anticoagulation therapy was given and there were no contraindications for anticoagulants.The ivc was reported as straight and measured 25cm in diameter.The device was stored and prepped per the instructions for use (ifu) and there was nothing unusual about the device prior to use.The temperature exposure indicator was verified to display a black doted pattern with a grey background clearly visible.There was no difficulty while advancing the deployment sheath to the deployment target.There were no acute bends, tortuosity, calcification, thrombosis, or stenosis at the target site.It was verified under fluoroscopy that no parts of the filter were within a side vessel.There was no reported separation of the device.The device was not returned for analysis.A product history record (phr) review of lot 17899773 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device, or procedural films to review, the reported ¿filter- incomplete expansion¿ cannot be confirmed or further clarified.Since the access site was not provided, it is unknown if the pre-existing thrombus within the vasculature influenced the reported difficulty.According to the instructions for use (ifu), the obturator serves to advance the filter from the storage tube into the sheath introducer and to advance the filter through the sheath introducer to the implantation site.During deployment, slowly advance the filter into the sheath introducer by advancing the obturator through the end of the storage tube until the filter is positioned well into the cannula of the sheath introducer.Continue to advance the filter until the marker on the obturator is positioned at the sheath introducer hemostasis valve.This indicates that the filter is at the distal tip of the sheath introducer but still fully within the sheath introducer.Note: if filter advancement is problematic when using a tortuous vessel approach, stop filter advancement prior to the curve.Advance the sheath introducer to negotiate the curve, then continue to advance the filter.Given the limited information provided and without the return of the device or procedural images available for review it is not possible to determine what factors may have contributed to the difficulty encountered by the customer.Neither the phr review nor the information available for review suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken at this time.

• Brand Name: TRAPEASE W/CSI INTRO KIT 55CM
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15478722
• MDR Text Key: 301941607
• Report Number: 9616099-2022-06009
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 20705032009444
• UDI-Public: (01)20705032009444(17)220831(10)17899773
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K020316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 466P306A
• Device Lot Number: 17899773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Date Device Manufactured: 10/01/2019
• 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
• Treatment: ANGIOJET MECHANICAL THROMBECTOMY SYSTEM; DENALI LONG-TERM RETRIEVABLE FILTER (BD); UNKNOWN GUIDEWIRE; UNKNOWN LARGE CSI
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 55 KG