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

Catalog Number EX061003C

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

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/24/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified.As the lot number for the device was provided, a review of the device history record 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.(expiry date: 12/2021).

Event Description

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

Event Description

It was reported that during a stent placement procedure, the stent allegedly fractured and remained inside the patient.The current patient status is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent 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 record 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.H10: d4 (expiry date: 12/2021).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.

Event Description

It was reported that during a stent placement procedure, the stent allegedly fractured.It was further reported that the component remained inside the patient.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 catheter sample is not available for evaluation.Provided images demonstrate the placed stents inside the vessel.Although the resolution is poor so that the single struts are not visible the contour of the stent confirms stent twisting on one image for one stent.A stent fracture is not visible.It was not known which of the two stents for the tied complaints was visible on the image that identified twisting.Based on the information available the investigation is closed with confirmed result 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 describes holding and handling of the system during deployment; in particular the instruction 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.While maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1 cm minimum.While maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.' in regards 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.' h10: b5, d4 (expiry date: 12/2021).H11: section a through f ¿ the information provide 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 two months post stent placement procedure, the stent allegedly fractured.It was further reported that the component remained inside the patient.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 catheter sample is not available for evaluation.Provided images demonstrate the placed stents inside the vessel.Although the resolution is poor so that the single struts are not visible the contour of the stent confirms stent twisting on one image for one stent.A stent fracture is not visible.It was not known which of the two stents for the tied complaints was visible on the image that identified twisting.Pre and post dilation was performed, the stent could be released without difficulty.Based on the information available the investigation is 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 describes holding and handling of the system during deployment; in particular the instruction 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.(¿) while maintaining a fixed handle position, rotate thumbwheel to obtain initial stent wall apposition of 1 cm minimum.(¿) while maintaining a fixed handle position, place your finger in front of the deployment slide and slide it from the distal to proximal end.' in regards 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.' h11: section a through f ¿ the information provide 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.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12368979
• MDR Text Key: 268213223
• Report Number: 9681442-2021-00455
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001449
• UDI-Public: (01)04049519001449
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061003C
• Device Lot Number: ANDZ2596
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2022
• 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 Outcome(s): Required Intervention