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

Catalog Number EX080801C

Device Problems Break (1069); Misfire (2532)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent vascular stent 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 record is currently being performed.The return of the sample is pending.However, an image was provided for review.The investigation of the reported event is currently underway.Expiry date: 07/2023.

Event Description

It was reported that during a stent placement procedure, the device allegedly partially deployed.It was further reported that the device was removed with surgical procedure.The patient is stable.

Event Description

It was reported that during a stent placement procedure, the device allegedly partially deployed.It was further reported that the device was removed with surgical procedure.The patient is stable.

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.Investigation summary: the delivery system and a photo of an x-ray screen were provided.The image is showing a moment of the deployment process, where the stent is partially deployed in the patient.However, based on the photo a malfunction or a device deficiency could not be confirmed.Based on the evaluation of the sample returned, it could be confirmed that the stent could only be partially deployed and a force transmitting component was broken.However, a definite root cause for the reported issue could not be determined.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found to be addressed, as the instruction for use states: "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." regarding preparation and use of accessories the instruction for use states: "a) gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.B) insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate length across the lesion to be stented via the introducer sheath" and "predilitation of the lesion should be performed using standard techniques." h10: d4 (expiry date: 07/2023).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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12931936
• MDR Text Key: 283696767
• Report Number: 9681442-2021-00613
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001777
• UDI-Public: (01)04049519001777
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX080801C
• Device Lot Number: ANFU4191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/05/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/17/2022
• 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
• Patient Outcome(s): Required Intervention