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

Catalog Number	EX062003CL
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a stent placement procedure using a lifestent device.During the procedure it was reported that the stent did not deploy and became caught on the sheath.The stent was removed from the sheath and taken out of the patient.The distal end of the stent was found to be broken off.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent products are identified in d2 and g4.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 and video were provided for review.The investigation of the reported event is currently underway.Section a through f: the information provided 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.
Event or Problem Description
On (b)(6) 2026, a patient underwent a stent placement procedure using a life stent solo vascular stent.During the procedure it was reported that the stent did not deploy and became caught on the sheath.The stent was removed from the sheath and taken out of the patient.The distal end of the stent was found to be broken off.There was no reported patient injury.
Additional Manufacturer Narrative
H11: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent solo vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent solo vascular stent products are identified in d2 and g4.Manufacturing review: 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 returned stent delivery system is in used condition such that the pusher is distal to the stent sheath indicating complete deployment.The system is in mechanical end position so that the deployment mechanism is blocked, and a force transmitting catheter joint in the catheter mid section is broken.A force transmitting tension wire inside grip is also broken.The stent was completely deployed; however, a segment of approximately 36 mm was fractured and missing, the disposition of the stent segment is not known.Images have not been provided for evaluation.A deployment failure cannot be confirmed; the investigation leads to confirmed result for stent fracture, and break of catheter in the mid section, and break of a force transmitting component inside grip.A manufacturing related issue could not be found.Therefore, the system was found over triggered in blocked end position so that the break of a force transmitting component inside grip was considered a consequence of over triggering after the reported deployment failure.The condition of the sample does not reflect the reported issue because the deployment mechanism including grip section is in fully used end position with pusher distal to stent sheath indicating complete deployment.It is not clear when the force transmitting catheter joint j1 broke, and when the stent fractured.Stent fracture may be related to handling after the event, but may also be related to a partial deployment which was not reported.Furtherly, limited procedural information was provided about the event so that a detailed re construction is not possible.Based on the investigation of the provided information, the investigation is closed as confirmed for catheter break, and stent fracture.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 state: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.', and 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.' regarding over triggering the instruction for use state: 'do not continue triggering the device following complete deployment of the implant.' regarding pta the instruction for use state: 'predilation of the lesion should be performed using standard techniques.' regarding accessories the instruction for use state: 'a) gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.B) insert a 0.035¿guidewire of appropriate length.Holding and handling of the system throughout the procedure was found sufficiently described.G3, h6 (device, component, method, result, conclusion).Section a through f: the information provided 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 SOLO VASCULAR STENT
• Common Device Name: VENOUS 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: 24332341
• Report Number: 9681442-2026-00015
• Device Sequence Number: 20062118
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303(17)270429(10)ANKR3788
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANKR3788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown