MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT

Catalog Number 5F070403C

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified.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.Expiry date: 07/2024.

Event Description

It was reported that a segment of the delivery system broke during a stent placement procedure, and the segment remained in the patient.Therefore, the stent could not be deployed.As reported an attempt to remove the segment was unsuccessful and the segment got lodged in a branch of a deep vessel.The current condition of the patient is unknown.

Event Description

It was reported that a segment of the delivery system broke during a stent placement procedure, and the segment remained in the patient.Therefore, the stent could not be deployed.As reported an attempt to remove the segment was unsuccessful and the segment got lodged in a branch of a deep vessel.The current condition of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the lifestent 5f vascular stent that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 delivery system was returned for evaluation.The distal segment of the inner catheter was found broken and the distal end including tip was missing.Based on evaluation of the sample returned, breakage of the inner catheter is confirmed.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the instructions for use supplied with this product the potential issue of resistance during the deployment procedure was found addressed.The instructions for use state: "if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used." and "if resistance is met while retracting the delivery system over a guidewire, remove the delivery system and guidewire together." regarding deployment the instructions 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." regarding the potential factor of insufficient pre dilation the instructions for use state: "pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instructions for use state: "5f (1.67 mm) or larger introducer sheath (¿) 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire." h10: d4 (expiry date: 07/2024), g3 h11: h6 (method, result) 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 : see h10.

• Brand Name: LIFESTENT 5F 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: 12646036
• MDR Text Key: 276827593
• Report Number: 9681442-2021-00552
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120442
• UDI-Public: (01)00801741120442
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

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: 5F070403C
• Device Lot Number: ANFU0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/06/2021
• 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