MAUDE Adverse Event Report: SYNTHES SELZACH VBS W/BALLOON MED; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.601S

Device Problems Break (1069); Burst Container or Vessel (1074)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/04/2015

Event Type  Injury  

Manufacturer Narrative

Additional product codes for this report include hrx.(b)(4).Device is an instrument and is not implanted or explanted.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing site: (b)(4) - manufacturing date: november 14, 2014 - expiry date: october 1, 2017.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure using a vertebral body stent with balloon on (b)(6) 2015.The balloon began to leak during expansion, which only allowed for the stent to expand three (3) to four (4) millimeters.The balloon burst as the surgeon attempted to pull it back.Parts of the burst balloon remained in the patient's vertebra and could not be removed.The vertebra also filled with cement thereafter.The procedure was completed with the achievement of "good anatomical alignment." a ten (10) minute procedural delay was noted.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Additional narrative: a manufacturing evaluation was completed: two instruments were returned, one system appears intact, and by the other system the balloon has burst transversally.The review of the manufacturing history of the production lot did not reveal any nonconformity.The complaint instrument was manufactured according to specifications and successfully passed all in-process inspections as well as the final inspection.The physician was unable to fully expand the stent due to a leakage of the delivery balloon.He tried to further expand the stent by introducing the vb balloon and using it for a post-dilatation.During this procedure the balloon burst and fractured when it was attempted to retrieve it.The technical analysis of the complaint instruments has shown that the stent delivery system is leaking when > 5 atm pressure is applied.The leakage site is located within a deep scratch near the tip of the balloon.The vb balloon on the other hand had burst in a transversal manner and the distal part of the balloon remained inside the patient.No clear origin of the fracture could be identified at the fracture edge, but several deep scratches were observed on the balloon surface.Based on the information available it appears that the complaint event occurred most probably due to unfavorable circumstances during the intervention (i.E.Balloon damage due to sharp solid bone fragments).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VBS W/BALLOON MED
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5369518
• MDR Text Key: 36050404
• Report Number: 3000270450-2016-10017
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 09.804.601S
• Device Lot Number: 0914046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR