MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG UNK FLUENCY PLUS STENT GRAFT

Catalog Number UNK FLUENCY PLUS STENT GRAFT

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Tachycardia (2095); No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 08/23/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The information provided by bard 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 bard.

Event Description

It was reported that post stent deployment in the svc the patient experienced tachycardia; a ct scan was performed that demonstrated the alleged stent migration to the left main pulmonary artery.The patient was reportedly taken to interventional radiology for stent removal.It was further reported that a combination of a pta balloon was inflated inside the stent for stability as a snare device captured and retrieved both devices inside a 16fr catheter.Upon successful removal of the stent, visual inspection identified a fragment of the stent had detached.Guided fluoroscopy reportedly demonstrated the small fragment located in the pulmonary artery.No attempt was made to retrieve the small stent fragment.The patient was reported to be hemodynamically stable at the conclusion of the stent removal.

Manufacturer Narrative

Manufacturing review: the lot history records could not be reviewed as the lot number was not reported.It is unknown if further complaints were reported for this lot number.It was not known whether the reported event was potentially related to a manufacturing issue.Investigation summary: as part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this particular case no sample and no images were provided for evaluation.Therefore, the reported problem could not be reproduced and the investigation will be closed with inconclusive result.Based on the information available and as no sample was returned for evaluation, a definitive root cause for the reported event could not be determined.Labeling review: in reviewing the current labeling it was found that the instructions for use (ifu) sufficiently address the potential risk as it is stated that stent graft migration is a potential complication.The potential contributing factors are addressed as the ifu states: 'careful attention of the operator is warranted to mitigate the possibility of distal (central venous system) migration of the stent graft during deployment.After deployment of approximately 15 mm of the stent graft, wait for the distal end of the stent graft to fully expand.' and 'special care must be taken to ensure that the appropriate size fluency plus endovascular stent graft is selected prior to introduction.In order to ensure sufficient wall apposition, it is recommended to oversize the stent graft relative to the healthy (non-diseased) portion of the vessel.' regarding the anatomy of the target lesion the ifu states 'careful attention should be paid to ensure the device is appropriately sized to the achievable lumen, taking into account any change to the stated treatment area diameter that may have resulted from previous interventions.Under-sizing the device may result in device migration.' and 'prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure.' the information provided by bard 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 bard.

Event Description

It was reported that post stent deployment in the svc the patient experienced tachycardia; a ct scan was performed that demonstrated the alleged stent migration to the left main pulmonary artery.The patient was reportedly taken to interventional radiology for stent removal.It was further reported that a combination of a pta balloon was inflated inside the stent for stability as a snare device captured and retrieved both devices inside a 16fr catheter.Upon successful removal of the stent, visual inspection identified a fragment of the stent had detached.Guided fluoroscopy reportedly demonstrated the small fragment located in the pulmonary artery.No attempt was made to retrieve the small stent fragment.The patient was reported to be hemodynamically stable at the conclusion of the stent removal.

• Brand Name: UNK FLUENCY PLUS STENT GRAFT
• Type of Device: STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7887630
• MDR Text Key: 120689078
• Report Number: 2020394-2018-01736
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P130029
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK FLUENCY PLUS STENT GRAFT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention