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

Catalog Number 5F070203C

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395); Mechanical Jam (2983)

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

Event Date 03/13/2023

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 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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 07/2025).

Event Description

It was reported that during the stent placement procedure in superficial femoral artery via proximal superficial femoral artery crossover access.The stent could not be deployed and placed properly.It was further reported that the red safety switch seemed to be jammed and couldn¿t be pulled fully.Reportedly, the physician was able to turn the wheel but the stent jumped a couple of centimeters distal so another stent must be deployed.The procedure was completed using another device.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 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: 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 sample was returned for evaluation.The returned sample was found in activated condition without stent that reportedly had been deployed inside patient; the safety slider was found in proximal end position, and the mechanics were found in used but fully functioning condition so that an indication for safety slider malfunction, difficult deployment, or stent jumping could not be found.Images demonstrating the stent during deployment were not provided.Therefore, the investigation is closed with inconclusive evaluation result.A definite root cause could not be determined based upon available information.System compatible 8f introducer and 0.018" guidewire were used for access, the lesion was pre dilated, and the vessel was not tortuous but calcified.Furtherly, the oversizing was 1mm which is according to instructions for use, and the system was correctly held at the stability sheath and kept stationary with the secured introducer.Based on available information, the investigation is closed with inconclusive evaluation result.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 state: 'unlock the safety lock slider by pulling it back towards the wheels from the locked position into the unlocked position.Ensure that the red safety lock slider is completely pulled back', and 'if it is suspected that the sterility or performance of the stent system has been compromised, the device should not be used'.The instructions for use further state: 'pre-dilatation of the lesion with a balloon dilatation catheter is recommended', and 'gain ipsilateral or contralateral femoral access utilizing an appropriate introducer sheath ¿ 5f (1.67 mm) or larger introducer sheath to insert a guidewire of appropriate length (table 3) and 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter'.Holding and handling of the system throughout deployment was found described, in particular the instructions for use state: 'confirm that the introducer sheath is secure and will not move during deployment'.'gently hold the stability sheath close to the introducer sheath and keep it stationary and under tension throughout deployment' and 'initiate stent deployment by rotating the large thumbwheel'.The stent size selection table mentions a 7mm stent inner diameter for a reference vessel diameter of 5.5-6.5mm which matches the used stent size.H10: d4 (expiration date: 07/2025), g3.H11: b5, h6 (method, result, conclusion).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.

Event Description

It was reported that during the stent placement procedure in superficial femoral artery via proximal superficial femoral artery crossover access, the stent could not be deployed and placed properly because the safety slider was jammed and couldn¿t be pulled fully.Reportedly, the physician was able to turn the wheel but the stent jumped a couple of centimeters distally so another stent had to be deployed.The procedure was completed using another device.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: 16709116
• MDR Text Key: 313165938
• Report Number: 9681442-2023-00125
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120428
• UDI-Public: (01)00801741120428
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F070203C
• Device Lot Number: ANGU3172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• 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