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

Catalog Number 5F060303C

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 11/30/2021

Event Type  Injury  

Event Description

It was reported that during the stent placement procedure, x-ray images allegedly demonstrated that the device hanging in the artery.It was further reported that stent was allegedly detached inside the patient.Reportedly broken stent was not able to remove form patient.Patient reported stable.

Manufacturer Narrative

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, images were provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the lifestent 5f vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent 5f vascular stent products are identified.Expiry date: 06/2024.

Event Description

It was reported that during the stent placement procedure, x-ray images allegedly demonstrated that the device segment hanging in the artery.It was further reported that the segment was fixed with two additional stent.Reportedly broken segment was not able to be removed from patient.Patient reported stable.

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 products that are cleared in the us.The pro code and 510 k number for the lifestent 5f 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.Investigation summary: the stent delivery system was returned for evaluation.Based on the condition of the sample, it is confirmed that the distal end of the inner catheter broke off.A repeating, one-sided kink pattern with regular intervals can be identified on the stent sheath.Based on the x-ray photos provided, a foreign segment can be identified, which is alleged to be segment of the delivery system.Therefore, the investigation is confirmed for the reported issue.However, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the instruction for use supplied with this product the potential issue of resistance during the deployment procedure was found addressed.The instruction 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 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." regarding the potential factor of insufficient pre dilation the instruction for use state: "pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' under materials required the instruction 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: b5, d4 (expiry date: 06/2024), g3, h6(device).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 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: 13083349
• MDR Text Key: 282964292
• Report Number: 9681442-2021-00641
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120053
• UDI-Public: (01)00801741120053
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F060303C
• Device Lot Number: ANFT3334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• 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