SOLUS BILIARY STENT AND INTRODUCER SET

Report

Report Number: 1037905-2020-00350
Event Type: Injury
Date Received: September 2, 2020
Date of Event: October 6, 2005
Report Date: September 23, 2020
Manufacturer: COOK ENDOSCOPY
Product Code: FGE
PMA / PMN Number: K851962
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

KAHALEH, M., SHAMI, V.M., CONAWAY, M.R., TOKAR, J., ROCKOFF, T., DE LA RUE, S.A., DE LANGE, E., BASSIGNANI, M., GAY, S., ADAMS, R.B., & YEATON, P. (2005). ENDOSCOPIC ULTRASOUND DRAINAGE OF PANCREATIC PSEUDOCYST: A PROSPECTIVE COMPARISON WITH CONVENTIONAL ENDOSCOPIC DRAINAGE. ENDOSCOPY 38(4), 355-359. DOI 10.1055/S-2006-925249. INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. THE REPORT COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. INVESTIGATION CONCLUSION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVALUATION. THE INSTRUCTIONS FOR USE (IFU) STATES, "ADDITIONAL COMPLICATIONS ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO BILIARY TRACT OR DUODENUM, OBSTRUCTION OF PANCREATIC DUCT, STENT MIGRATION." THE IFU ALSO CONTAINS, "POTENTIAL COMPLICATIONS: THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST." THE ZSS PRODUCT LINE WAS TRANSFERRED TO COOK MEDICAL IRELAND IN 2011. COMPLAINTS AND DISTRIBUTION OF ZSS STENTS ARE NOW MONITORED BY COOK IRELAND. THESE STENTS HAVE A THREE YEAR EXPIRATION DATE, THEREFORE ALL STENTS SUSPECTED TO USED IN THIS OCCURRENCE WERE MANUFACTURED AND DISTRIBUTED BY COOK MEDICAL ENDOSCOPY ARE BEYOND THEIR EXPECTED LIFE. THE STENTS WERE THEREFORE EXCLUDED FROM THE RISK ASSESSMENT AND COMPLAINT REVIEW. PRIOR TO DISTRIBUTION, ALL SOLUS PANCREATIC STENTS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME BECAUSE THE ZSS WAS TRANSFERRED TO COOK IRELAND IN 2011. THE ZSS STENTS ARE REMOVABLE IMPLANTABLE DEVICES WHERE THE IMPLANT TIME IS NO MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN AND A THREE YEAR EXPIRATION DATE THEREFORE ALL DEVICES DISTRIBUTED ARE BEYOND THEIR EXPECTED LIFE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

Description of Event or Problem · 0

THE FOLLOWING WAS PUBLISHED REGARDING A COOK SOLUS BILIARY STENT AND INTRODUCER SET IN A CLINICAL LITERATURE ARTICLE. ¿PANCREATIC PSEUDOCYSTS ARE A COMPLICATION IN UP TO 20% OF PATIENTS WITH PANCREATITIS. ENDOSCOPIC MANAGEMENT OF PSEUDOCYSTS BY A CONVENTIONAL TRANSENTERIC TECHNIQUE, I. E. CONVENTIONAL TRANSMURAL DRAINAGE (CTD), IS WELL DESCRIBED¿ ONE OR TWO 10-FR DOUBLE-PIGTAIL ENDOPROSTHESES (ZSS-10-X-RB; WILSON COOK) WERE PLACED ACROSS THE CYSTOENTEROSTOMY FISTULA AT THE DISCRETION OF THE ENDOSCOPIST. ALL CTD CYSTOENTEROSTOMY FISTULAS WERE CREATED USING A 10-FR CYSTOENTEROSTOME. FOLLOWING ACCESS TO THE PSEUDOCYST, ONE OR TWO 10-FR DOUBLE-PIGTAIL ENDOPROSTHESES WERE PLACED. STENT MIGRATION WAS DEFINED AS A COMPLICATION WHEN AN INTERVENTION WAS REQUIRED TO EXTRACT THE STENT, EITHER FROM THE PSEUDOCYST OR THE ENTERAL LUMEN¿ IN ONE PATIENT, LATE DOUBLE-PIGTAIL STENT MIGRATION RESULTED IN SMALL-BOWEL PERFORATION REQUIRING A LIMITED SMALL-BOWEL RESECTION [SUBJECT OF THIS REPORT]..." AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT EXPERIENCED SMALL-BOWEL PERFORATION REQUIRING A LIMITED SMALL-BOWEL RESECTION DUE TO THIS OCCURRENCE.

Additional Manufacturer Narrative · 1

KAHALEH, M., SHAMI, V.M., CONAWAY, M.R., TOKAR, J., ROCKOFF, T., DE LA RUE, S.A., DE LANGE, E., BASSIGNANI, M., GAY, S., ADAMS, R.B., & YEATON, P. (2005). ENDOSCOPIC ULTRASOUND DRAINAGE OF PANCREATIC PSEUDOCYST: A PROSPECTIVE COMPARISON WITH CONVENTIONAL ENDOSCOPIC DRAINAGE. ENDOSCOPY 38(4), 355-359. DOI 10.1055/S-2006-925249. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem · 1

THE FOLLOWING WAS PUBLISHED REGARDING A COOK SOLUS BILIARY STENT AND INTRODUCER SET IN A CLINICAL LITERATURE ARTICLE. ¿PANCREATIC PSEUDOCYSTS ARE A COMPLICATION IN UP TO 20% OF PATIENTS WITH PANCREATITIS. ENDOSCOPIC MANAGEMENT OF PSEUDOCYSTS BY A CONVENTIONAL TRANSENTERIC TECHNIQUE, I. E. CONVENTIONAL TRANSMURAL DRAINAGE (CTD), IS WELL DESCRIBED¿ ONE OR TWO 10-FR DOUBLE-PIGTAIL ENDOPROSTHESES (ZSS-10-X-RB; WILSON COOK) WERE PLACED ACROSS THE CYSTOENTEROSTOMY FISTULA AT THE DISCRETION OF THE ENDOSCOPIST. ALL CTD CYSTOENTEROSTOMY FISTULAS WERE CREATED USING A 10-FR CYSTOENTEROSTOME. FOLLOWING ACCESS TO THE PSEUDOCYST, ONE OR TWO 10-FR DOUBLE-PIGTAIL ENDOPROSTHESES WERE PLACED. STENT MIGRATION WAS DEFINED AS A COMPLICATION WHEN AN INTERVENTION WAS REQUIRED TO EXTRACT THE STENT, EITHER FROM THE PSEUDOCYST OR THE ENTERAL LUMEN¿ IN ONE PATIENT, LATE DOUBLE-PIGTAIL STENT MIGRATION RESULTED IN SMALL-BOWEL PERFORATION REQUIRING A LIMITED SMALL-BOWEL RESECTION [SUBJECT OF THIS REPORT]..." AN UNINTENDED SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT EXPERIENCED SMALL-BOWEL PERFORATION REQUIRING A LIMITED SMALL-BOWEL RESECTION DUE TO THIS OCCURRENCE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
949556	SOLUS BILIARY STENT AND INTRODUCER SET	FGE, CATHETER, BILIARY, DIAGNOSTIC	FGE	COOK ENDOSCOPY		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	OLYMPUS GF-UC30P OR GT-UCT140 ENDOSCOPE