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

Model Number EX061003CS

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.

Event Description

It was reported that during a stent placement procedure, the distal radiopaque markers were allegedly not visible under fluoroscopy.Therefore, another device was used to complete the procedure.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the lot records have been 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.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented that could have led to the event reported.Based on the lot history records, stents with correct dimension were used during the assembly of this lot.Investigation summary: based on the delivery system returned for evaluation, no device deficiency could be confirmed.The device was found to be unused and intact, the tip of the delivery system was found undamaged.As no x-rays were provided, the insufficient visibility reported could not be verified.Based on the delivery system returned and the information provided, the reported issue could not be reproduced and the investigation is closed with inconclusive result.A definite root cause could not be determined.Labeling review: in reviewing the current labeling it was found that the design of the lifestent xl delivery system is sufficiently described.It states that the stent delivery sheath has a radiopaque zone at its distal end and a second radiopaque zone proximal to the stent.The stent implant of a lifestent xl has no radiopaque markers.The description of the delivery system and the stent is illustrated in the ifu.

Event Description

It was reported that during a stent placement procedure, the distal radiopaque markers were allegedly not visible under fluoroscopy.Therefore, another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8345435
• MDR Text Key: 137015857
• Report Number: 9681442-2019-00021
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001272
• UDI-Public: (01)04049519001272
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2019
• Device Model Number: EX061003CS
• Device Catalogue Number: EX061003CS
• Device Lot Number: ANBV0537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2019
• Date Manufacturer Received: 03/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1