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

Model Number	EX061003CS
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8345435
• Report Number: 9681442-2019-00021
• Device Sequence Number: 2035445
• Product Code: NIP
• UDI-Device Identifier: 04049519001272
• UDI-Public: (01)04049519001272
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P070014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2019

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 01/22/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1