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

Catalog Number EX061203C

Device Problems Fracture (1260); Material Twisted/Bent (2981)

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

Event Date 10/17/2022

Event Type  malfunction  

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.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, images were provided for review.The investigation of the reported event is currently underway.Medical device expiration date: 03/2023.

Event Description

It was reported that during a stent placement procedure, the stent allegedly had fractured.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure, the stent allegedly had fractured.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: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the catheter sample is not available for evaluation.Provided images confirm stent twist.Strut fracture cannot be confirmed because single struts are not visible.The vessel was not tortuous/ calcified, and the lesion was pre and post dilated.The user did not experience difficulty during deployment, and an irregular strut pattern was not identified upon deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describes holding and handling of the system during deployment; in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment.To ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.Do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position.' in regards 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.' h10: d4 (expiration date: 03/2023).H11: section a through f - the information provided by bd represents all of 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.

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: 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.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.Investigation summary: the catheter sample is not available for evaluation.Provided images confirm stent twist.Strut fracture cannot be confirmed because single struts are not visible.The vessel was not tortuous/ calcified, and the lesion was pre and post dilated.The user did not experience difficulty during deployment, and an irregular strut pattern was not identified upon deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describes holding and handling of the system during deployment; in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment.(¿) to ensure the most accurate placement, firmly hold the black system stability sheath throughout deployment.(¿) do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.Initiate stent deployment by rotating the thumbwheel in the direction of the arrows, while holding the handle in a fixed position.' in regards 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.' h10: d4 (expiration date: 03/2023), g3.H11: section a through f - the information provided by bd represents all of 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 ten days post stent placement procedure, the stent allegedly had fractured.There was no reported patient injury.

• Brand Name: LIFESTENT XL
• 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: 15787342
• MDR Text Key: 307599368
• Report Number: 9681442-2022-00328
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001463
• UDI-Public: (01)04049519001463
• 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,Followup,Followup
• Report Date: 01/12/2023

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 Catalogue Number: EX061203C
• Device Lot Number: ANFQ3338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/28/2022; 01/12/2023
• Supplement Dates FDA Received: 12/14/2022; 01/19/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 67 KG