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

Catalog Number EX080801C

Device Problems Break (1069); Misfire (2532); Material Deformation (2976)

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

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified 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: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of sample is pending.However, images was provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2024).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, only two cm can be deployed.It was further reported that quick release mechanism blocked and after pushing and pulling, the stent was allegedly unable to be deployed.Reportedly, the stent could not be unfolded properly and the stent allegedly stretched out.There was no reported patient injury.

Event Description

It was reported that during a stent placement procedure, only two centimeters of the stent could be deployed without problem.It was further reported that quick release mechanism blocked and after pushing and pulling, the stent allegedly deployed.Reportedly stent could not unfold properly and the stent stretched out.Additionally pta balloon and stent were required for treatment.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 catheter sample was returned; the system was partially activated, and a force transmitting component was found broken inside the grip which made a complete deployment impossible.Various components were found broken/ deformed which made a detailed re construction impossible.One provided x-ray image demonstrates the deployed stent inside the patient; the stent is visibly elongated.The investigation leads to confirmed result to break of a force transmitting component leading to partial stent deployment, and subsequent stent elongation.A 6f introducer was in use, the vessel was not calcified, and the lesion was pre dilated.The stent was placed to extend/ overlap a previously placed stent inside the truncus tibiofibularis.Based on the investigation of the provided information, the investigation is closed as confirmed for stent twisting, and stent foreshortening.A definite root cause for the reported event could not be determined.Placement in the truncus tibiofibularis would be off label use.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' holding and handling of the system throughoug the procedure was found sufficiently described; in particular the instructions 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.' in regards to access/ accessories the instructions for use state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath (.) insert a 0.035 inch (0.89 mm) diameter guidewire'.The instructions for use further state: 'predilation of the lesion should be performed using standard techniques.', and 'the safety and effectiveness of stent overlapping in the middle (p2) and distal popliteal artery (p3) has not yet been established.', the lifestent vascular stent is indicated for the treatment of atherosclerotic lesions in the superficial femoral artery (sfa) and popliteal artery.H10: d4 (expiry date: 09/2024), g3, h6 (device) h11: b5, 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.

• 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: 17080922
• MDR Text Key: 316717173
• Report Number: 9681442-2023-00217
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001777
• UDI-Public: (01)04049519001777
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 06/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• 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: ANGW1249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• 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