SYNETURE

Additional Manufacturer Narrative

POST MARKET VIGILANCE (PMV) RECEIVED TWO DEVICES SEALED WITH THE APPROPRIATE PACKAGING, REPRESENTATIVE SAMPLES TO THIS COMPLAINT. MI CROSCOPIC AND TACTILE INSPECTION OF THE SUTURE NOTED NO ABNORMALITIES. MICROSCOPIC INSPECTION OF THE NEEDLE SWAGE BARREL NOTED APPROPRIATE CRIMP MARKS. NO SUTURE TRANSFER MATERIAL WAS FOUND INSIDE THE BARREL OF THE SWAGE AND CRIMP MARKS WERE NOTED IN THE SUTURE TIPS THAT ATTACHED TO THE NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS RELEASED MEETING ALL MEDTRONIC QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. HOWEVER, A MANUFACTURING FAULT WAS IDENTIFIED DURING PRODUCT ANALYSIS. THE ROOT CAUSE OF THE OBSERVED CONDITION WAS DETERMINED TO BE A RESULT OF A MANUFACTURING ACTIVITY. IT WAS TRACED TO POOR SUTURE INSERTION INTO THE NEEDLE DURING THE ATTACHING PROCESS. IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, WHEN SUTURING THE VESSEL DURING AN ILIAC FEMORAL POPLITEAL THROMBOENDARTERECTOMY PROCEDURE, THE NEEDLE BROKE AT SWAGE. THEY USED ANOTHER SUTURE PACK TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.