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

Catalog Number 5F050601C

Device Problems Break (1069); Positioning Failure (1158); Entrapment of Device (1212)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified 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.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation; however, a photo was provided for review.The investigation of the reported event is currently underway.Device not returned.

Event Description

It was reported that during a vascular procedure, the stent was allegedly unable to be deployed and the device got jammed.It was further reported that the wire got caught.There was no reported patient injury.

Event Description

It was reported that during a vascular procedure, the stent was allegedly unable to be deployed and the device got jammed.It was further reported that the wire got caught.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 products that are cleared in the us.The pro code and 510k number for the lifestent 5f vascular stent 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, previously.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 for evaluation.One images demonstrates the used sample after the event on the table.The image confirms break and detachment of catheter parts.The stent was not visible so that a deployment failure cannot be confirmed.The image does not confirm compatibility issue with a guidewire.A detailed reconstruction of the entire issue was not possible based on the image.Potential factors that could have led or contributed to the reported event have been evaluated.Therefore, previous investigations of similar complaints have been reviewed.Deployment failure may be related to increased friction during deployment caused by difficult anatomy or challenging placement site.Placement without pre dilation or inadequate accessories may be contributing factors to friction increase.Damage caused by transport, unpacking, or preparation may be further contributing factors.In this case poor information was provided about the procedure such that indication/ placement site, accessories used, patient condition, and procedural details were not known; it was known that the user locked and unlocked the system when it jammed.Stuck guidewire, break, and detachment were considered cascading events caused by release force increase, deployment failure, deformation, and subsequent handling.Based on the information available the investigation is closed with confirmed result for catheter break.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: '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.' in regards to accessories and access the instruction for use state: 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath', 'insert a guidewire of appropriate length and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter (¿).' in regards to pta the instruction for use state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended.' holding and handling of the system throughout deployment including unpacking and preparation was found sufficiently described.The device was not returned.

• 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
• MDR Report Key: 10704660
• MDR Text Key: 213899915
• Report Number: 9681442-2020-20008
• 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: 03/23/2021

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: 5F050601C
• Device Lot Number: ANDZ2186
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 05/27/2021
• Supplement Dates FDA Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other