Description of Event or Problem · 1
MEDTRONIC REGULATORY AFFAIRS EUROPE HAD RECEIVED A LETTER FROM BRITAIN'S MEDICAL DEVICE AGENCY QUESTIONING AN ARTICLE FROM "ENDOSCOPY JUNE 1997" ABOUT AN EC-50 MIGRATION, THAT LED TO COMPLICATIONS. IT WAS THEN FORWARDED TO MEDTRONIC INSTENT. MARCH 26, 1998 WAS THE FIRST TIME MEDTRONIC INSTENT WAS AWARE OF THE COMPLAINT. THE INCIDENT OCCURRED IN JUNE/JULY 1995. THE STENT WAS IMPLANTED IN A 76 YEAR OLD WOMAN WHO HAD AN OBSTRUCTING PERIAMPULLARY TUMOR. STENT DEPLOYMENT AND PLACEMENT WAS FINE (2/95). ON 6/1/95 PT WAS SEEN AGAIN FOR CHOLANGITIS WITH JAUNDICE AND PLAIN ABDOMINAL RADIOGRAPH INDICATED THAT THE STENT HAD MIGRATED DISTALLY INTO THE DUODENUM. THE PROXIMAL END OF THE STENT LAY APPROX 2 CM WITHIN THE DILATED COMMON BILE DUCT; NEITHER END WAS VISIBLE ENDOSCOPICALLY. MULTIPLE ATTEMPTS TO REMOVE THE STENT WITH FOREIGN BODY FORCEPS AND SNARES FAILED. CLINICAL IMPROVEMENT WITH ANTIBIOTIC THERAPY WAS SEEN AND THE STENT WAS LEFT IN PLACE, WITH SPONTANEOUS DISCHARGE BEING AWAITED. MORE SYMPTOMS PREVAILED ON 6/21/1995. ATTEMPTS TO REMOVE AGAIN FAILED. A 9.6 FR PLASTIC ENDOPROSTHESIS WAS INSERTED INTO THE DILATED COMMON BILE DUCT LEADING TO A DISCHARGE OF PURULENT BILE AND IMMEDIATE CLINICAL IMPROVEMENT. TWO DAYS LATER A 9.6 FR PLASTIC ENDOPROSTHESIS AND NASOBILIARY DRAINAGE CATHETER WERE INSERTED AGAIN LEADING TO CLINICAL IMPROVEMENT. DRAINAGE INTO THE DUODENUM WAS NOT ATTAINED. THE PT WAS REFFERED TO SURGERY FOR REMOVAL OF THE STENT AND A BILIARY-DIGESTIVE BYPASS OPERATION. ACHOLECYSTOJEJUNOSTOMY AND GASTROJEJUNOSTOMY WERE CARRIED OUT ON 7 JULY 1995. THE PT DIED THE FOLLOWING DAY DUE TO A FULMINANT POSTOPERATIVE INTRAPERITONEAL HEMORRHAGE.