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

Catalog Number EX051503C

Device Problems Loss of or Failure to Bond (1068); Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 05/11/2023

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 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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 10/2023).H11: 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.H3 other text : device not returned.

Event Description

It was reported that during a stent placement procedure, the stent allegedly felt resistance when retracting the device from the patient.It was further reported that the device allegedly broke at the time of removal.Furthermore, the tip of the introducer was allegedly stayed inside the patient.Reportedly, the tip was removed with the help of the guidewire.There was no reported patient injury.

Event Description

It was reported that during a stent placement in the superficial femoral artery and distal popliteal artery via the right common femoral artery, the stent allegedly felt resistance when retracting the device from the patient.It was further reported that the device allegedly broke at the time of removal.Furthermore, the tip of the introducer was allegedly stayed inside the patient.Reportedly, the tip was removed with the help of the guidewire.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 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 without stent that reportedly had been deployed inside patient.The guidewire lumen including pusher lumen was found detached from the metal hypotube inside grip which confirms the detachment of a bonding joint.Provided images demonstrate the sample on the table after the event, and the guidewire lumen is visibly broken distal of the pusher which confirms break.A 6f introducer with 0.035" guidewire were used for access, and the user did not experience problems during deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for break and detachment of an adhesive joint.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: 'if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together.', and 'visually confirm the delivery system integrity after removal.' the instruction for use further 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.' in regards to access/ accessories the instruction for use 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.' the safety and effectiveness of this device for use in treatment of in-stent restenosis has not been established.H10: b5, d4 (expiration date: 10/2023), g3, h6 (device).H11: 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 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: 17104686
• MDR Text Key: 317835596
• Report Number: 9681442-2023-00221
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519007779
• UDI-Public: (01)04049519007779
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX051503C
• Device Lot Number: ANFX0231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/11/2023
• 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