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

Catalog Number UNK LIFESTENT STENT SYSTEM

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation, however image have been provided.The investigation of the reported event is currently underway.

Event Description

It was reported that during an angioplasty procedure, the stent got entrapped by another stent.It was further reported that the stent allegedly fractured.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a manufacturing related issue could not be evaluated because the lot number was not known.Investigation summary: the physical sample was not returned for evaluation/inspection.Two images were provided with poor resolution so that the stent struts were not visible; a strut structure evaluation leading to a confirmed result was not possible which led to an inconclusive evaluation result.Based on the information available and because no sample was provided for evaluation, a definite root cause for the reported event could not be determined.Labeling review: it was not known which lifestent product was used for this event.A specific labeling reference was therefore not applicable.Accessories to be used, description of deployment leading to regular strut pattern including tracking, accessories, and lesion preparation are part of the different lifestent instructions for use.

Event Description

It was reported that during a two stent overlapping procedure in a thrombotic sfa via a contralateral approach, groin access, the delivery system allegedly entrapped with the first deployed stent.However, the health care provider was able to maneuver the device and deploy the stent.It was further reported that the stent was identified under imaging allegedly fractured after it was released from the delivery system.Reportedly, two additional stents were used to pin the existing stents against the vessel wall.There was no reported patient injury.

• Brand Name: LIFESTENT STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10348674
• MDR Text Key: 204939814
• Report Number: 9681442-2020-00190
• Device Sequence Number: 1
• Product Code: NIP
• 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: 08/12/2020

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: UNK LIFESTENT STENT SYSTEM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 08/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 104