MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLUENCY PLUS ENDOVASCULAR STENT GRAFT

Catalog Number FEM12060

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record review is currently being performed.The device has not been returned to the manufacturer for evaluation; however, a image is provided for a review.The investigation of the reported event is currently underway.(expiry date: 02/2023).

Event Description

It was reported that during a vascular stent graft procedure, the device allegedly had deployment difficulty and positioning problem.It was further reported that the marker on the sheath dislodged and migrated to the pulmonary artery and doctor confirmed that no intervention required.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were 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.Investigation summary: the device was not returned to the manufacturer for evaluation; however medical image was provided and reviewed.Based on the investigation of the provided image, it was confirmed the detached marker band broke off and migrated as it was reported.The investigation for the reported break, detachment and migration of the marker band was confirmed.In this case an 7f sheath was in use to dilate the vessel and no introducer sheath was used to advance the delivery system to the lesion and resistance was experienced.The lesion was predilated and the system was flushed prior to use; the lesion was not calcified or tortuous.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu state: 'if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device.' regarding the use of accessories the ifu states: 'materials required for the fluency plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)'; the packaging pictograms indicate a minimum introducer size of 10f.Furthermore, the ifu states: 'prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment.' h10: d4 (expiry date: 02/2023),g4 h11: e1,h6(method,result and conclusion) h11: section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

Event Description

It was reported that during a vascular stent graft procedure, the device allegedly had deployment difficulty and positioning problem.It was further reported that the marker on the sheath dislodged and migrated to the pulmonary artery; however,physician confirmed that no medical intervention was required.There was no reported patient injury.

• Brand Name: FLUENCY PLUS ENDOVASCULAR STENT GRAFT
• Type of Device: ENDOVASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10703609
• MDR Text Key: 212079282
• Report Number: 2020394-2020-20173
• 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: 10/26/2020

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: FEM12060
• Device Lot Number: ANEP4869
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 10/28/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 79