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

Catalog Number VIEL14120

Device Problems Positioning Failure (1158); Material Deformation (2976)

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

Event Date 09/25/2022

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 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: 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 stent delivery system was returned for evaluation and the stent was still loaded in the catheter and in place.The distal part of the outer blue catheter was deformed by flattening which leads to confirmed results for deformation and failure to deploy is considered a cascading results.It was reported that, a 6f introducer was used and the lesion was pre-dilated.Based on the available information and the returned sample analysis, the investigation is closed with confirmed results for catheter deformation and failure to deploy is considered a cascading event.A definite root cause of the reported incident can not be identified.The intended use of the device to treat iliac vein compression syndrome indicates an off-label use.Labeling review: in reviewing the relevant labeling it was found that the instructions for use sufficiently address the potential risks.With regards to warnings, the instructions for use states "visually inspect the lifestar vascular stent system to verify that the device has not been damaged due to shipping or improper storage.Do not use damaged equipment".Regarding accessories, the instructions for use states "the 6f delivery system requires a minimum 8f guiding catheter, or a minimum 6f introducer sheath.Via the femoral route, insert a 0.035 inch (0.89 mm) guidewire under fluoroscopic guidance through the appropriate introducer sheath or guiding catheter and pass the lesion".The packaging pictograms indicate an introducer size of 6f and a 0.035" guidewire.With regards to the procedure, the instructions for use states "pre-dilatation of the stricture is recommended.Selection of an appropriately sized balloon dilatation catheter is left to the discretion of the treating physician".The lifestar vascular stent system is indicated for the treatment of atherosclerotic lesions in the common and external iliac artery.The intended placement in the vein indicates an off-label use.H10: d4 (expiration date: 02/2025).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: see h10.

Event Description

It was reported that during a stent placement procedure in the left iliac vein via the left femoral vein, the stent was flushed and delivered to the lesion over the guide wire as no resistance was met.It was further reported that after the release position was adjusted and the delivery rod was straightened, the outer sheath was found to be unable to be retracted for stent release.Reportedly, the stent release allegedly failed despite multiple adjustments to its position.The procedure was completed using another device.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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17116057
• MDR Text Key: 317834593
• Report Number: 9681442-2023-00226
• 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
• Report Date: 05/31/2023

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: VIEL14120
• Device Lot Number: ANGP0845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/13/2023
• 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