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

Catalog Number 5F061201C

Device Problem Material Deformation (2976)

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

Event Date 02/19/2024

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 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: 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, an image was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2025) 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 pending return.

Event Description

It was reported that during a stent placement procedure in the distal superficial femoral artery via the proximal superficial femoral artery, the stent allegedly foreshortened.The procedure was completed by placing an additional stent.There was no reported patient injury.

Manufacturer Narrative

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.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 catheter sample is not available for evaluation.Provided x-ray image demonstrates the placed stent inside vessel including a digital length measurement.The length measurement and appearance of the stent confirm stent foreshortening.A 0.035" guidewire with 6f introducer were used for access, the vessel was not tortuous but calcified; the lesion was pre dilated.The user did not experience difficulty during deployment, and the introducer was secured; the intended site was seen between the markers before deployment.Based on the investigation of the provided information, the investigation is closed as confirmed for stent foreshortening.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.Holding and handling of the system throughout deployment was found sufficiently described.In particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment.' and 'gently hold the stability sheath close to the introducer sheath and keep it stationary and under tension throughout deployment.Remove slack from the stent system held outside the patient'.Regarding accessories the instructions for use state: 'gain ipsilateral or contralateral femoral access utilizing 5f (1.67 mm) or larger introducer sheath.Insert a guidewire of 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter'.Regarding pta the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' (expiration date: 05/2025), (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.

Event Description

It was reported that during a stent placement procedure in the distal superficial femoral artery via the proximal superficial femoral artery, the stent allegedly foreshortened.The procedure was completed by placing an additional stent.There was no reported patient injury.

• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18915731
• MDR Text Key: 337803550
• Report Number: 9681442-2024-00045
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120015
• UDI-Public: (01)00801741120015
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F061201C
• Device Lot Number: ANGS1540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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