MAUDE Adverse Event Report: TUTOGEN MEDICAL GMBH TUTOMESH BOVINEPERICARDIUM; SURGICAL MESH

Catalog Number 68542

Device Problem Material Rupture (1546)

Patient Problems Hematoma (1884); High Blood Pressure/ Hypertension (1908); Lymphoma (3263)

Event Date 03/04/2015

Event Type  Injury  

Event Description

(b)(4) and tutogen medical (b)(4), a wholly owned subsidiary of (b)(4) received a complaint on 05/05/2015 reporting a tutomesh graft was utilized in a thoracic wall replacement procedure and removal of 4 ribs on (b)(6) 2015.The graft was implanted with tension onto surrounding ribs.Approximately two weeks post operatively, the patient underwent revision of a hematoma.During the procedure, it was noted that the graft had ruptured.The patient underwent a revision procedure on (b)(6) 2015.The complaint notification indicated the patient's medical history was significant for sarcomatoid differentiated pulmonary carcinoma with no irradiation therapy initiated.

Manufacturer Narrative

Method: graft was not returned to rti for evaluation, therefore a re-review was performed of the manufacturing records, sterilization run reports, environmental monitoring results, quality control/assurance reviews adn release, and the complaint database for related complaints associated with the lot.Results: no deviations were noted during processing for lot# nz217160410.The graft underwent a validated sterilization methodology; tutoplast which includes terminal sterilization by gamma irradiation after packaging.To date, rti has distributed 1 xenograft from the lot.There is 1 related complaint associated with the physician, this surgery type, but not the same lot.Environmental data and records generated during and around the time of processing for lot # nz217160410 were acceptable.Conclusion: given that no deviations were noted in record re-review, graft id (b)(4) was manufactured to specification prior to distribution; and the complex nature of the surgical procedure, it is more plausible that the patient's surgical outcome was associated with a source or event extrinsic to the xenograft implant.

• Brand Name: TUTOMESH BOVINEPERICARDIUM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): TUTOGEN MEDICAL GMBH; neunkirchen am brand ; GM
• Manufacturer (Section G): TUTOGEN MEDICAL GMBH
• Manufacturer Contact: karen britt ; 11621 research circle; alachua, FL 32615 ; 3864188888
• MDR Report Key: 4823667
• MDR Text Key: 5901458
• Report Number: 3002924436-2015-00004
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081538
• 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: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 68542
• Device Lot Number: NZ17160410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT PROVIDED.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR