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

Catalog Number 5F061203C

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976)

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

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, images and video were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2022).Device not returned.

Event Description

It was reporting that during stent placement procedure on left lower limb via right femoral artery, the stent allegedly difficult to deploy and stent foreshortened.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 5f vascular stent system products that are cleared in the us.The pro code and 510k number for the lifestent 5f vascular stent system products is 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 sample was not available.Images/ video were provided demonstrating a stented vessel.The resolution is poor so that the strut structure is not visible in detail.A strut evaluation for foreshortening was not possible.A stent length measurement was not possible due to poor resolution and missing adequate scaling information.However, the stent appeared too short on the image for a 120mm stent and was relatively short in relation to the overlapping stent in proximal position with a 150mm length.Therefore, foreshortening was considered as confirmed.The lesion was pre dilated, but a long system was used with popliteal access for an ipsilateral procedure.Based on the information available the investigation is closed with confirmed result for 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.The instructions for use closely describes holding and handling of the system throughout deployment including unpacking and preparation; in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment.The second hand should be used to support the stent delivery system.Gently hold the stability sheath close to the introducer sheath and keep it stationary and under tension throughout deployment'.The instructions for use further state: 'it is recommended to use the 80 cm working length device for ipsilateral procedures.The longer working length of the 135 cm device may potentially be challenging for the user to keep straight for ipsilateral procedures.Failure to keep the device straight may impede the optimal deployment of the implant', and 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath'.Regarding pre dilation the instructions for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' h10: d4 (expiry date: 01/2022).H11: section a through f ¿ the information provide 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 reporting that during stent placement procedure on left lower limb via right femoral artery, the stent allegedly difficult to deploy and stent foreshortened.There was no reported patient injury.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11330748
• MDR Text Key: 259341987
• Report Number: 9681442-2021-00039
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F061203C
• Device Lot Number: ANEN2068
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other