GRAFTMASTER

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

Description of Event or Problem

IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS INITIALLY MODIFIED USING ORBITAL ATHERECTOMY (OA). FOLLOWING OA, THE LESION WAS FURTHER PREPARED WITH A NON-COMPLIANT (NC) BALLOON, AND STENTING WAS PERFORMED USING TWO XIENCE SIERRA DRUG-ELUTING STENTS (3.50X18MM IN PROXIMAL LAD AND 3.50X23MM IN DISTAL LAD). POST STENT INTRAVASCULAR ULTRASOUND (IVUS) IMAGING REVEALED SIGNIFICANT STENT MALAPPOSITION OF THE 3.50X23 SIERRA STENT. TO ADDRESS THIS, A LARGER NC BALLOON WAS USED FOR POST-DILATION; HOWEVER, REPEAT IVUS STILL SHOWED PERSISTENT MALAPPOSITION. A FURTHER UPSIZED NC BALLOON WAS EMPLOYED IN AN ATTEMPT TO ACHIEVE OPTIMAL STENT APPOSITION, BUT THIS RESULTED IN PERFORATION OF THE LAD ARTERY. MULTIPLE ATTEMPTS WERE MADE TO SEAL THE PERFORATION USING GRAFTMASTER COVERED STENTS; HOWEVER, THE GRAFTMASTER STENT DELIVERY SYSTEMS (2.80X26MM, 3.50X19MM, 3.50X26MM, AND 4.0X19MM) COULD NOT BE SUCCESSFULLY DELIVERED ACROSS THE LESION DUE TO INTERACTIONS WITH THE ANATOMY AND INTERACTIONS BETWEEN THE GUIDE WIRES AND GUIDING CATHETER. GIVEN THE FAILED PERCUTANEOUS APPROACH AND ONGOING RISK, THE PATIENT WAS URGENTLY REFERRED FOR CORONARY ARTERY BYPASS GRAFTING (CABG). THE PATIENT EXPIRED LATER THAT DAY. PER THE PHYSICIAN, IT IS UNKNOWN IF THE PERFORATION CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUES APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.