MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LIFESTENT SOLO VASCULAR STENT SYSTEM; VASCULAR STENT GRAFT

Model Number EX072003CL

Device Problems Break (1069); Positioning Failure (1158); Misfire (2532); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified in section has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified respectively.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 was returned to the manufacturer for evaluation.The investigation of the reported event 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, the device allegedly failed to deploy.The system was removed and another product was used for treatment.There was no reported patient injury.

Event Description

It was reported that during a stent graft deployment procedure, the device allegedly failed to deploy.The system was removed and another product was used for treatment.There was no reported patient injury.

Manufacturer Narrative

The catalog number has not been cleared in the us, but is similar to the fluency plus endovascular stent graft products that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft products are identified.Manufacturing review: based on the lot history review the used product complied with all manufacturing specifications leading to final device release.In reviewing manufacturing and quality records, no relevant manufacturing process changes were implemented that could have led to the event reported.No manufacturing anomalies or deviations, which may have caused or contributed to the event reported, have been identified.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the delivery system could only partially deploy the stent.A force transmitting component was found broken in the mid section of the system which made a successful deployment impossible.The broken embedded metal components at the fracture site indicated that a high release force was present when the break occurred.An indication for a manufacturing related issue could not be found.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling for this product it was found that the instructions for use (ifu) sufficiently address the potential risks.The ifu states: 'do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit.' in regards to guidewire, the ifu states: 'insert a 0.035¿ guidewire of appropriate length (.) advance the stent system over the 0.035¿ guidewire through the sheath introducer (.)'.In regards to pre dilation the ifu states: 'predilation of the lesion should be performed using standard techniques.' update: device code + description2,3; eval code & desc - results 1; eval code & desc - conclusion1.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7770913
• MDR Text Key: 116706674
• Report Number: 2020394-2018-01416
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004402
• UDI-Public: (01)04049519004402
• 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: 08/30/2018

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 Model Number: EX072003CL
• Device Catalogue Number: EX072003CL
• Device Lot Number: ANCP3041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/09/2018
• Supplement Dates Manufacturer Received: 08/21/2018
• Supplement Dates FDA Received: 08/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 78