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

Catalog Number EX070603C

Device Problems Break (1069); Positioning Failure (1158)

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

Event Date 04/02/2021

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.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 and a break of a force transmitting component inside of the delivery system is confirmed, causing the impossibility to deploy the stent using the thumbwheel or the fast track deployment lever.The investigation is confirmed for reported issues.Based on the information available a definite root cause for the event reported could not be identified.Labeling review: in reviewing the relevant labeling for this product the potential risk was found addressed.The instructions for use states: "if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit." correct stent deployment was found to be properly described.E.G.Regarding preparation the instructions for use states: "predilitation of the lesion should be performed using standard techniques." (expiry date: 07/2022).

Event Description

It is reported that during a stent placement procedure, the device allegedly failed to deploy.There was no reported patient injury.

Event Description

It is reported that during a stent placement procedure, the device allegedly failed to deploy.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 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: 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 and a break of a force transmitting component inside of the delivery system is confirmed, causing the impossibility to deploy the stent using the thumbwheel or the fast track deployment lever.The investigation is confirmed for reported issues.Based on the information available a definite root cause for the event reported could not be identified.Labeling review: in reviewing the relevant labeling for this product the potential risk was found addressed.The instructions for use states: "if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible, and replace with a new unit." correct stent deployment was found to be properly described.E.G.Regarding preparation the instructions for use states: "predilitation of the lesion should be performed using standard techniques." h10: b5, d4 (expiry date: 07/2022), g3.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 : see h10.

• 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: 13646022
• MDR Text Key: 286644906
• Report Number: 9681442-2022-00061
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001586
• UDI-Public: (01)04049519001586
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX070603C
• Device Lot Number: ANEU3330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• 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