MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTAR VASCULAR STENT

Catalog Number VIEL08120

Device Problem Material Deformation (2976)

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

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar 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 device has not been returned to the manufacturer for evaluation.However, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 09/2022).Device not returned.

Event Description

It was reported that during stent deployment procedure via superficial femoral artery, the stent allegedly elongated to 160 mm.It was further reported that stent deployed successfully.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 lifestar vascular stent that are cleared in the us.The pro code and 510 k number for the lifestar vascular stent are 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 returned for evaluation.A photo was provided showing an x-ray of a stent placed in the left iliac artery.However, the body of the stent and the individual stents struts could not be identified, due to low quality of the photo.Therefore, an alleged elongation of the placed stent could not be verified.No scale is displayed on the photo to determine the length of the stent.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use sufficiently address the potential risks.The instructions for use states: "the stent experiences length changes less than 10% during deployment if appropriate oversizing is used.(¿) use the following guidelines for proper stent diameter selection.For target lumens ranging from 5 mm to 9 mm, select a stent with an unconstrained diameter of 1 mm larger than the target lumen.For target lumens ranging from 10 mm to 13 mm, select a stent with an unconstrained diameter of 1 to 2 mm larger than the target lumen." correct stent deployment was found sufficiently described as the instructions for use states: "center the proximal stent markers and both overlapping distal markers (stent markers and marker band on the outer catheter) across the stricture.The radiopaque markers on the stent indicate the ends of the compressed stent and the length of the expanded stent." furthermore, the instructions for use describes with an image on the packaging material that the stent length is measured without the stent markers.H10: d4 (expiry date: 09/2022), g3 h11: h6(method, result, conclusion) 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.H3 other text : device not returned.

Event Description

It was reported that during stent deployment procedure via superficial femoral artery, the stent allegedly elongated to 160 mm.It was further reported that stent deployed successfully.There was no reported patient injury.

• Brand Name: LIFESTAR 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: 11776742
• MDR Text Key: 249050305
• Report Number: 9681442-2021-00292
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080007
• 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: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VIEL08120
• Device Lot Number: ANDW4210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Sex: Female