MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC LIFESTENT VASCULAR STENT SYSTEM; STENT, SUPERFICIAL, FEMORAL ARTERY

Model Number VASCULAR 6X170; 130

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Pain (1994); Numbness (2415)

Event Date 05/14/2014

Event Type  No Answer Provided  

Event Description

Two years ago, the patient's right superior femoral artery (sfa) was stented.Within the last month, the patient was experiencing claudication pain in the right calf and right thigh for a couple of weeks.Patient also complained of numbness in the right foot if does not keep the leg down.Patient had a right leg angiogram that showed a long segment of sfa occlusion with "multiple stent fractures" and not amenable to percutaneous revascularization.The patient had an angiogram with attempts at recanalization which were unsuccessful.Patient underwent vascular surgery.This facility is seeing an increase in the number of stent fractures.Fractures are occurring from one month to three years post procedure.Staff/physicians do not know why this is happening.The physicians are trained and experienced in using these devices.In each case, the defective devices remain implanted in the patients.And, for each case, additional medical intervention was required.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL, FEMORAL ARTERY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 3908494
• MDR Text Key: 4668585
• Report Number: 3908494
• Device Sequence Number: 1
• Product Code: NIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Model Number: VASCULAR 6X170; 130
• Device Lot Number: ANWA2031
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 84