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

Catalog Number EX080801C

Device Problems Break (1069); Fracture (1260); Misfire (2532)

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

Event Date 06/08/2023

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 vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent 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 return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).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.H3 other text : device pending return.

Event Description

It was reported that during a stent placement procedure, the stent allegedly got stuck after having been released for about ten millimeters.It was further reported that various attempts were made, but failed to continue releasing the stent.Furthermore, the stent allegedly fractured at the distal end.Reportedly, the stent was forcefully removed; however, the distal end of the fractured stent cannot be removed and was at the intended placement site.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 vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent 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 sample was returned for evaluation.The returned sample was found in used condition with partially deployed, and fractured stent.The distal stent end was missing.The system was found disassembled with various breaks and deformation of force transmitting components so that a detailed re construction was not possible.The provided image matches the condition of the returned sample.The investigation leads to confirmed result for break of, partial deployment, and stent fracture.The product was used off label for a tips procedure which is off label, and which was considered a significant factor.Based on the investigation of the provided information, the investigation is closed as confirmed for break, partial deployment, and stent fracture.A definite root cause for the reported event could not be determined.However, the reported indication represents an off label use of the device and is considered a significant factor for the reported issue.Labeling review: in reviewing the relevant labeling for this product the potential issue 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.' the lifestent vascular stent is indicated for the treatment of atherosclerotic lesions in the superficial femoral artery (sfa) and popliteal artery.H10: b5, d4 (expiry date: 07/2024), g3, h6 (device) h11: h6 (method, 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.

Event Description

It was reported that during a transjugular intrahepatic portosystemic shunt stent placement procedure, the stent allegedly got stuck after having been released for about ten millimeters.It was further reported that various attempts were made, but the system failed to continue releasing the stent.Furthermore, the user forcefully removed the system, and the stent allegedly fractured at the distal end.Reportedly, the distal end of the fractured stent cannot be removed and was at the intended placement site.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: LIFESTENT 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: 17279564
• MDR Text Key: 318771300
• Report Number: 9681442-2023-00259
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001777
• UDI-Public: (01)04049519001777
• 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
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX080801C
• Device Lot Number: ANGU1055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2023
• 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