MAUDE Adverse Event Report: 3M HEALTH CARE COBAN 2 LITE LAYER COMPRESSION SYSTEM

Catalog Number 2794

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

Patient Problem Pulmonary Embolism (1498)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

A 4-6 information was not supplied by reporter.Pulmonary embolism occurs at a known rate postoperatively following joint replacement surgery.When the report was received on (b)(6) 2017, there was no evidence to suggest that the occurrence of the pulmonary embolism was related to the use of 3m coban 2 lite layer compression system post total knee arthroplasty.On (b)(6) 2017 3m received the 4th report of a pulmonary embolism in this study.Threem contacted the study investigators to obtain additional patient details regarding operative duration, patient comorbidities and medical history.No additional information has been received to date.Although there was still no evidence to suggest that the occurrence of pulmonary embolism was related to the use of 3m coban 2 lite layer compression system post total knee arthroplasty, on (b)(6) 2017 3m made the decision to send mdr reports for all four cases.Case 2110898-2017-000146 was sent for report received on (b)(6) 2017.On (b)(6) 2017 mdr report numbers 2110898-2017-00148, 2110898-2017-00149 and 2110898-2017-00150 were sent based on trend analysis.(b)(4).Threem will continue to monitor complaints and trends for this type of report.

Event Description

An independent study investigator reported coban 2 lite layer compression system was applied to a (b)(6) male patient following a total knee arthroplasty.On post-op day 2, the patient complained of knee pain and the wrap was removed for further investigation and tests.Later the same day, a diagnosis of pulmonary embolism was confirmed.The patient reportedly received full anticoagulation treatment.

Manufacturer Narrative

3m received a formal letter from the university (b)(6) regarding their investigation of the four pulmonary embolisms that occurred within the investigator-initiated research study entitled "the use of 3m¿ coban¿ 2 lite layer compression system post-total knee arthroplasty".The university (b)(6) consulted with two independent content experts to investigate the etiology of the pulmonary embolisms and to determine whether they were related to the study intervention, i.E., the 3m¿ coban¿ 2 lite layer compression system.In brief, the independent content experts reached consensus that the four pes were likely unrelated to the study intervention 3m¿ coban¿ 2 lite layer compression system.

• Brand Name: COBAN 2 LITE LAYER COMPRESSION SYSTEM
• Type of Device: COBAN 2 LITE LAYER COMPRESSION SYSTEM
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): MANUFACTURING MEDICAL DEVICES; edisonstrasse 6; d-59157; kamen, ; GM
• Manufacturer Contact: karen krenik, bsn ; 3m center building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517333091
• MDR Report Key: 7107295
• MDR Text Key: 94482910
• Report Number: 2110898-2017-00150
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2017
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 78 YR