MAUDE Adverse Event Report: BENVENUE MEDICAL, INC. KIVA VCF TREATMENT SYSTEM; PMMA BONE CEMENT, NDN, LOD

Catalog Number KIV2200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 06/09/2015

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2015, a kiva vcf procedure was performed and the patient had two levels (l1 and l2) treated successfully.Products were discarded by the hospital post kiva procedure as the devices performed as expected.Upon a follow-up visit on (b)(6) 2015, the patient reported lumbar pain and subsequent mri revealed additional collapse at l1, with posterior fragmentation and minor retropulsion into the spinal canal.The treating physician reported that the original treatment was without issue, although there was a very large cleft and that it extended to the posterior wall.The physician felt that the event was likely due to a vertical fracture line that existed prior to the original procedure, and that it was difficult to see on imaging.On (b)(6) 2015, the physician treated the level with vertebroplasty procedure and the patient is reportedly doing well.No additional information was provided.

Manufacturer Narrative

Evaluation summary: the device was not returned as there was no reported device malfunction.A review of the lot history record confirmed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the information reviewed, the fractured vertebral body reported in this incident appears to be related to patient/procedural conditions.The patient effect of 'pain or lack of pain relief' is listed in the kiva vcf treatment system instructions for use ((b)(4)) as a known possible complication associated with kiva procedures.In this case, the reported lumbar pain and subsequent mri revealed additional collapse at l1, was likely a result of a vertical fracture line that existed prior to the original procedure, and that it was difficult to see in imaging, as indicated by the treating physician.In this case, although a definitive cause for the reported patient effects cannot be determined, there is no indication of a product deficiency.Based on the information reviewed, there is no indication of a product deficiency; therefore, no corrective action is necessary at this time.Benvenue will continue to monitor these types of incidents and take the necessary steps to correct any further findings.

• Brand Name: KIVA VCF TREATMENT SYSTEM
• Type of Device: PMMA BONE CEMENT, NDN, LOD
• Manufacturer (Section D): BENVENUE MEDICAL, INC.; santa clara CA 95054
• Manufacturer Contact: anil patel ; 3052 bunker hill lane, suite 120; santa clara, CA 95054 ; 4084549370
• MDR Report Key: 4906138
• MDR Text Key: 6835620
• Report Number: 3007033608-2015-00001
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2016
• Device Catalogue Number: KIV2200
• Device Lot Number: 15057009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR