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

Model Number FEM12060

Device Problems Material Invagination (1336); Failure to Advance (2524); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.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.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 during a stent graft deployment procedure in the left arm venous graft, the endovascular stent graft delivery system allegedly could not be advance over the guidewire to the treatment site.Initial access was obtained, no introducer sheath was used; however, a 7fr sheath was introduced into the vessel due to the failure to advance the stent graft to the lesion.Furthermore, the 7fr sheath was then upsized to an 8fr.Sheath and the stent graft delivery system again failed to advance; therefore, the device was removed and upon removal the distal tip of the deployment system was identified missing.Although multiple contrast injections were performed to identify the location of the detached tip, the detached tip was not identified.Reportedly, a new stent graft system was prepped and deployed without incident.The patient was hemodynamically stable at the conclusion of the procedure.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Visual inspection: a stent graft delivery system was received for evaluation.The safety clip was removed and not returned.The 2-way stopcock and the tuohy-borst valve were found opened.The distance between the y-injection adapter and the pin vise handle was 160mm.The outer sheath was found to be in good condition.The distal tip of the outer sheath was found to be invaginated.The stent graft was found to be flush with the radiopaque marker band.The distance between the proximal end of the stent graft and the pusher was 7mm.Functional/performance evaluation: a flushing test and a guide wire patency test (with a device compatible 0.035'' guide wire) were successfully performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: as a result of the investigation performed the complaint was confirmed for tip invagination, which could be a consequence of the reported advancing problems.However, based on the available information and the evaluation of the returned sample, a definite root cause for the reported failure could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding potential damages the ifu states: "examine the packaging and endovascular system to determine if there is any damage, defects or if the sterile barrier is compromised.Do not use the device if any of these conditions are observed." regarding preparation of the device the ifu states that "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline." furthermore, the ifu states regarding the use of accessories: "materials required for the fluency¿ plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter.".

Event Description

It was reported that during a stent graft deployment procedure in the left arm venous graft, the endovascular stent graft delivery system allegedly could not be advance over the guidewire to the treatment site.Initial access was obtained, no introducer sheath was used; however, a 7fr sheath was introduced into the vessel due to the failure to advance the stent graft to the lesion.Furthermore, the 7fr sheath was then upsized to an 8fr.Sheath and the stent graft delivery system again failed to advance; therefore, the device was removed and upon removal the distal tip of the deployment system was identified missing.Although multiple contrast injections were performed to identify the location of the detached tip, the detached tip was not identified.Reportedly, a new stent graft system was prepped and deployed without incident.The patient was hemodynamically stable at the conclusion of the procedure.

• 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
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6682204
• MDR Text Key: 78911735
• Report Number: 9681442-2017-00206
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 04049519008646
• UDI-Public: (01)04049519008646(17)200303(10)ANBQ0448
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2020
• Device Model Number: FEM12060
• Device Catalogue Number: FEM12060
• Device Lot Number: ANBQ0448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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 Age: 43 YR