MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMPLICI-T BAND; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 6701

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that this annuloplasty band was implanted and explanted on the same day.The reason for explant is unknown.No further adverse patient effects were reported.

Manufacturer Narrative

Additional information received indicated that the attempted repair failed during the implant procedure due to the patient's native tissue.There was no failure of the device.The device was explanted and replaced during the same procedure.No further adverse patient effects were reported.

Manufacturer Narrative

Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SIMPLICI-T BAND
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6152384
• MDR Text Key: 61652432
• Report Number: 2025587-2016-01950
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00613994759276
• UDI-Public: 00613994759276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2016
• Device Model Number: 6701
• Device Catalogue Number: 670100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2015
• 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: 75 YR