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

Catalog Number EX061703C

Device Problems Break (1069); Positioning Failure (1158); Fracture (1260); Misfire (2532)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported that during a stent placement procedure, while deploying the stent with deployment wheel, the stent was allegedly not getting opened.The procedure was completed using another device.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: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2024).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 during a stent placement procedure, while deploying the stent with deployment wheel, the stent was allegedly not getting opened.The procedure was completed using another device.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 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 issues.Investigation summary: the sample was returned for evaluation.The returned sample was found with fully activated deployment mechanism, and one end of the stent was returned as a separate fractured piece.In addition, the guidewire lumen assembly was broken, and separated from the system which does not necessarily have to lead to a deployment failure.In sum, the condition of the returned sample does not match the reported deployment failure.A reconstruction of the reported event was not possible which leads to inconclusive result.Based on the investigation of the provided information, the condition of the returned sample leads to as analyzed coding for break, and fracture.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 for a deployment failure was found addressed.The instruction for use state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible and replace with a new unit.' holding and handling of the system was found sufficiently described, in particular the instruction for use state: 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.' the instruction for use further state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire (.)', and 'predilation of the lesion should be performed using standard techniques.' regarding increased friction upon removal, the instruction for use state: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' h10: d4 (expiry date: 08/2024), g3.H11: h6 (result, conclusion).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 : see h10.

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 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 issues.Investigation summary: the sample was returned for evaluation.The returned sample was found with fully activated deployment mechanism with the stent sheath being in proximal end position, and one end of the stent was returned as a separate fractured piece.In addition, the guidewire lumen assembly was broken, and separated from the system.In sum, a re construction of the reported event was not possible which leads to inconclusive result.However, the condition of the returned sample leads to as analyzed coding for catheter break, and stent fracture.Based on the investigation of the provided information, the condition of the returned sample leads to coding for break, and fracture.The condition of the sample does not match the provided information so that a reconstruction was not possible.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 for a deployment failure was found addressed.The instruction for use state: 'if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible and replace with a new unit.' holding and handling of the system was found sufficiently described, in particular the instruction for use state: 'do not hold the silver stent delivery sheath at any time during deployment.Do not constrict the stent delivery sheath during stent deployment.' the instruction for use further state: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire and 'predilation of the lesion should be performed using standard techniques.' regarding increased friction upon removal, the instruction for use state: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' 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 during a stent placement procedure, the stent was allegedly partially deployed with only the distal part of stent was getting opened.The procedure was completed using another device.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: 18231067
• MDR Text Key: 329280537
• Report Number: 9681442-2023-00386
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 01/03/2024

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: EX061703C
• Device Lot Number: ANGV2756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/11/2023; 02/01/2024
• Supplement Dates FDA Received: 12/19/2023; 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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