MAUDE Adverse Event Report: ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

Catalog Number FTM10040

Device Problems Detachment Of Device Component (1104); Malposition of Device (2616)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/15/2014

Event Type  Injury  

Event Description

It was reported that during placement of the tracheobronchial stent graft in a venous anastamosis of an a/v graft in the cephalic vein, the radiopaque marker band detached from the delivery system and became wrapped around the distal end of the stent graft, preventing full expansion of the stent graft.The stent could be opened during subsequent successful balloon dilatation; however, the marker band detached and floated to the pulmonary artery.Reportedly, there are no current plans to retrieve the marker band.The patient will be monitored and is reported to be doing fine at this time.There was no reported patient injury.

Manufacturer Narrative

The lot number has been provided.The device history records are being reviewed.The investigation is currently underway.

• Brand Name: FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH AND CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4176435
• MDR Text Key: 5090875
• Report Number: 9681442-2014-00134
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: FTM10040
• Device Lot Number: ANYB1690
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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 Outcome(s): Required Intervention