MAUDE Adverse Event Report: CALDERA MEDICAL INC. VERTESSA LITE Y-MESH 26X4X3CM; POP MESH

Model Number VERTESSA LITE YMESH 26X4X3CM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

This case took place during (b)(6) 2017 but was only recently reported to cmi by the surgeon.The rep has tried following up with the office for a lot number but does not expect that it will be obtainable.She will attempt to follow-up again.Cmi customer service was asked to provide a list of lot numbers at the hospital during (b)(6) 2017.Cross-referencing the stock of vly2643 at this hospital during the time-frame reported suggests that the lot number used may have been lot#h06002, however without confirmation from the hospital, it cannot be known for certain that this was the lot used during this case.In this case, the last two orders of vly2643 at the reporting facility took place in (b)(6) 2017, both from lot#h06002.Previous to that, the were orders placed in (b)(6) 2017.This suggests that the lot numbers used in (b)(6) may likely have been used for this case.The lot history record (lhr) for cal-vly2643 lot#h06002 was reviewed and does not contain any non-conformances to contribute to the issue reported.The lot was inspected and received passing results per qcic.Additionally, the product was used within the expiration date of 06/24/2022.No waivers, deviations, or ncrs reported.Sterilization results were also passing.The adverse event reported is a known risk associated with the procedure, however, risks are noted in the warnings/adverse reaction section of each product's instructions for use (ifu).Specifically, the adverse reactions section lists "foreign body response or reaction and inflammation" as potential adverse reaction associated with surgery using implantable materials of this type.When used as intended and per the product ifu, the benefit to the patient for the intended use outweighs these risks.These risks have been mitigated through product labeling (ifu) and surgeon training.All products are by prescription use only and are restricted for use by physicians trained in performing procedures for treatment, as indicated in the product labeling.Additionally, design controls exist for all products during the design phase for inherently safe design with quality testing to support.

Event Description

Sales rep reports an adverse event from a surgeon that occurred during (b)(6) 2017.The rep states that they were not made aware of the event until recently.The surgeon states that a patient was implanted with vertessa lite y-mesh 26x4x3cm and experienced severe inflammation and infection post-surgery.The surgeon states they are unsure what caused it but doubts that it was the result of the mesh implant.The patient was treated with antibiotics.Follow up information from the surgeon states that the patient had pain near her sacral spine.The surgeon was not sure what was the cause but states that it seemed like discitis, epidural abscess, or osteomyelitis.He treated the patient with 3-4 rounds of antibiotic and reports that the patient seems to be doing better.He did not think the adverse event was related to the mesh but rather to the patient's anatomy or tissue.No lot numbers are available and no further information has been received.

• Brand Name: VERTESSA LITE Y-MESH 26X4X3CM
• Type of Device: POP MESH
• Manufacturer (Section D): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer (Section G): CALDERA MEDICAL INC.; 5171 clareton drive; agoura hills CA 91301
• Manufacturer Contact: vicki gail ; 5171 clareton drive; agoura hills, CA 91301 ; 8184837602
• MDR Report Key: 7491340
• MDR Text Key: 107503903
• Report Number: 3003990090-2018-01442
• Device Sequence Number: 1
• Product Code: OTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: VERTESSA LITE YMESH 26X4X3CM
• Device Catalogue Number: CAL-VLY2643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization