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

Catalog Number 5F060803C

Device Problems Misfire (2532); Device Dislodged or Dislocated (2923)

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

Event Date 10/01/2021

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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 06/2024).Device not returned.

Event Description

It was reported that during a stent placement procedure, the stent allegedly got loosened as it passed through the introducer sheath.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: 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 stent delivery system was returned for evaluation.The stent was found partially deployed and the safety lock slider was found unlocked.Based on the condition of the sample, it is confirmed that the user could only partially deploy the stent.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product, correct application, potential risks as well as potential contributing factors were found addressed.Regarding preparation the instructions for use states: "verify that the safety lock slider is still in the locked position." and "pre-dilatation of the lesion with a balloon dilatation catheter is recommended." regarding accessories required to facilitate delivery and deployment of the lifestent 5f vascular stent system the instructions for use lists: 5f (1.67 mm) or larger introducer sheath; 0.014 inch (0.36 mm) - 0.035 inch (0.89 mm) diameter guidewire.Regarding deployment the instructions for use states: "if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit." based on the instructions for use supplied with this product the lifestent 5f vascular stent system is intended to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery (sfa) and popliteal artery.In this case the intended application of the device and the intended placement site is unknown.H10: (expiry date: 06/2024).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.

Event Description

It was reported that during a stent placement procedure, the stent allegedly got loosened as it passed through the introducer sheath.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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12710091
• MDR Text Key: 278771787
• Report Number: 9681442-2021-00567
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120084
• UDI-Public: (01)00801741120084
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5F060803C
• Device Lot Number: ANFT1213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• 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