MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT XL VASCULAR STENT

Catalog Number EX061203C

Device Problem Fracture (1260)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified in d2 and g4.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a video and photos were provided for review.The investigation of the reported event is currently underway.H10: d4: (expiration date: 04/2025).H11: section a: through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that approximately one month post a stent placement, the stent was allegedly found to be broken.There was no reported patient injury.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified in d2 and g4.H10: manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation.X-ray images and videos were provided for both tied complaints demonstrating patient treatment.Single stent struts are not visible due to poor image quality so that a stent fracture cannot be confirmed.Although single stent struts are not visible, the contour of the stent in proximal position confirms stent twisting.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instruction for use closely describe holding and handling of the system for regular deployment, in particular the instruction for use state: 'confirm that the introducer sheath is secure and will not move during deployment.Firmly hold the black system stability sheath throughout deployment.Do not hold the silver stent delivery sheath.Do not constrict the stent delivery sheath during stent deployment'.In regard to pta the instruction for use state: 'predilation of the lesion should be performed using standard techniques' and 'post stent expansion with a pta catheter is recommended'.In regard to access and accessories the instruction for use state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire'.Stent fracture was found mentioned as a potential adverse event that may occur.H10: (expiration date: 04/2025).H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text: device not returned.

Event Description

It was reported that approximately one month post a stent placement, the stent was allegedly found to be broken.There was no reported patient injury.

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent xl vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent xl vascular stent products are identified.Manufacturing review: based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the sample was not returned for evaluation.X-ray images and videos were provided demonstrating patient treatment.Single stent struts are not visible due to poor image quality so that a stent fracture cannot be confirmed.Although single stent struts are not visible, the contour of the stent in proximal position confirms stent twisting.An 8f introducer with 0.035" guidewire were used for access, the vessel was not tortuous/calcified, and the lesion was pre and post dilated.The system was correctly held at the stability sheath, the user did not experience difficulty during deployment, and there was no irregularity observed in the stent strut structure; torque was neither felt nor exerted on the system.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.The instructions for use closely describe holding and handling of the system for regular deployment, in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment.Firmly hold the black system stability sheath throughout deployment.Do not hold the silver stent delivery sheath.Do not constrict the stent delivery sheath during stent deployment'.In regard to pta, the instructions for use state: 'predilation of the lesion should be performed using standard techniques' and 'post stent expansion with a pta catheter is recommended'.In regard to access and accessories the instructions for use state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire'.Stent fracture was found mentioned as a potential adverse event that may occur.Expiration date: 04/2025.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that approximately one month post a stent placement in the superficial femoral artery, the stent was allegedly found to be broken.There was no reported patient injury.

• Brand Name: LIFESTENT XL VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19113232
• MDR Text Key: 340799225
• Report Number: 9681442-2024-00094
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061203C
• Device Lot Number: ANHR0890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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