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

Catalog Number EX080803C

Device Problems Entrapment of Device (1212); Fracture (1260)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the lifestent vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products 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.However, a photo and a video were provided for review.The investigation of the reported event is currently underway.(expiry date: 07/2023).

Event Description

It was reported that during a stent placement procedure through right femoral artery, the sheath was retracted and visible resistance was felt.It was further reported that the stent was fractured.There was no reported patient injury.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 vascular stent products that are cleared in the us.The pro code and 510 k number for the lifestent vascular stent products 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.Investigation summary: the sample was not available for evaluation.Provided x-ray movie demonstrates one undeployed stent end in the iliac vessel.Due to poor resolution a partial deployment and / or stent fracture cannot be identified; the other stent end is not visible.One further image demonstrates the product outside patient without visible damage.Therefore, the alleged partial deployment/stent fracture cannot be reproduced which leads to inconclusive evaluation result.The lesion was not pre dilated, and a 0.018" guidewire in combination with a 6f introducer was used for access.The vessel was not tortuous but slightly calcified.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'if excessive force is felt during stent deployment, do not force the delivery system.Remove the delivery system and replace with a new unit.' in regards to accessories the instructions for use state: 'gain femoral access at the appropriate site using a 6f (2.0 mm) or larger introducer sheath.Insert a 0.035 inch (0.89 mm) diameter guidewire of appropriate length (see table) across the lesion to be stented via the introducer sheath'.The instructions for use further state: 'predilitation of the lesion should be performed using standard techniques.' holding and handling of the system throughout deployment was found sufficiently describe.H10: (expiry date: 07/2023).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 a stent placement procedure through right femoral artery, the sheath was retracted and visible resistance was felt.It was further reported that the stent was fractured.There was no reported patient injury.

• Brand Name: LIFESTENT 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: 13521460
• MDR Text Key: 285832113
• Report Number: 9681442-2022-00030
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001784
• UDI-Public: (01)04049519001784
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/16/2022

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: EX080803C
• Device Lot Number: ANFU0273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/14/2022
• Supplement Dates Manufacturer Received: 03/11/2022
• Supplement Dates FDA Received: 03/16/2022
• 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 Age: 85 YR
• Patient Sex: Male