GEENEN PANCREATIC STENT
Report
- Report Number
- 3001845648-2020-00716
- Event Type
- Injury
- Date Received
- October 1, 2020
- Date of Event
- November 15, 2013
- Report Date
- February 25, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- PMA / PMN Number
- K900923
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
COMPONENT CODE (ANNEX G): G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE. THE GEENEN PANCREATIC STENT OF UNKNOWN LOT NUMBER AND RPN INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION ALL GEENEN PANCREATIC STENT DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. AS PER INFORMATION STATED IN THE PAPER WITH 81 PATIENTS ¿A 5-10 FR PANCREATIC ENDOPROSTHESIS (GEENEN OR ZIMMON PANCREATIC STENT, WILSON-COOK MEDICAL INC.) WAS INTRODUCED INTO THE MAIN PANCREATIC DUCT¿ AFTER PANCREATIC SPHINCTEROTOMY. IT WAS NOTED THAT THE TRANSPAPILLARY PLACEMENT OF THE GENNEN/ ZIMMON PANCREATIC STENTS IS ON-LABEL, HOWEVER THE USE FOR A PANCREATIC LEAK IS OFF LABEL USE OF THE DEVICE. THE POTENTIAL USER ERROR OF THE STENT EXCEEDING THE 3 MONTHS INDWELL PERIOD WAS ALSO NOTED HERE, AS PER ARTICLE ¿THE TRANSPAPILLARY STENTS WERE EXCHANGED AFTER EVERY CECT (3, 6, 12, 24 MONTH), AND WERE MAINTAINED FOR AN AVERAGE OF 17 MONTHS (12-24).¿ AS PER INFORMATION REPORTED IN ¿THREE PATIENTS A MIGRATION OF STENTS WAS OBSERVED. IN ONE CASE THE MIGRATION TOOK PLACE INTO THE LUMEN OF THE COLLECTION AND THE STENT WAS REMOVED WITH DORMIA BASKET.¿ IT WAS CONFIRMED BY CLINICAL INPUT THAT THE REMOVED STENT WAS THE DOUBLE PIGTAIL (ZSO-7-10) DEVICE DUE TO THE LOCATION OF THE MIGRATION. AS THE ZSO-7-10, GEENEN AND ZIMMON PANCREATIC STENTS WERE USED IN EACH PATIENT AND THE REMAINING MIGRATED STENTS CANNOT BE IDENTIFIED IT WILL BE ASSUMED THAT A WORST-CASE SCENARIO THAT ALL STENTS IN THE REMAINING PATIENTS MIGRATED. IT WAS NOTED THAT IN 6 OF THE INITIAL 112 PATIENTS ENDOSCOPIC PANCREATOGRAPHY WAS NOT ACHIEVABLE AS THE DUODENUM WAS INACCESSIBLE BECAUSE OF COMPRESSION ON GI TRACT, A FURTHER 8 PATIENTS DID NOT COMPLETE THE PROCEDURE DUE TO MASSIVE BLEEDING FOLLOWING THE EXECUTION OF THE STOMA OPENING, STOMACH PERFORATION, SEPSIS, COLLECTION PERFORATION, AND DEATH. 18 PATENTS ALSO EXPERIENCED STOMA BLEEDING. THESE HAVE ALL BEEN DISASSOCIATED FROM OUR DEVICES BY CLINICAL INPUT. PERFORATION OF THE GASTROINTESTINAL TRACT WALL OCCURRED IN FOUR PATIENTS AND WAS RELATED TO THE CST-10 DEVICE. A SECONDARY INFECTION NOTED IN 38 PATIENTS HAS BEEN ATTRIBUTED TO THE PATIENT¿S UNDERLYING CONDITION AND WAS NOT RELATED TO ONE OF OUR DEVICES. THE CUSTOMER IS NOTIFIED AS PER INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE, IN THE POTENTIAL COMPLICATIONS SECTION: ¿THOSE ASSOCIATED WITH PANCREATIC STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE PANCREATIC TRACT OR DUODENUM, OBSTRUCTION OF THE COMMON BILE DUCT, STENT MIGRATION.¿ AND IN THE PRECAUTIONS SECTION ¿THIS DEVICE SHOULD NOT BE LEFT INDWELLING FOR MORE THAN THREE MONTHS OR AS DIRECTED BY A PHYSICIAN. PERIODIC EVALUATION IS RECOMMENDED.¿ IT SHOULD BE NOTED THAT THE DEVICE WAS USED OFF-LABEL, OUTSIDE ITS INTENDED USE STATED IN THE INSTRUCTIONS FOR USE "THIS DEVICE IS USED TO DRAIN OBSTRUCTED PANCREATIC DUCTS" AND IN THE NOTES SECTION ¿DO NOT USE THIS DEVICE FOR ANY PURPOSE OTHER THAN STATED INTENDED USE.¿ A DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED TO OFF-LABEL USE OF THE DEVICE, WHEN THE DEVICE IS USED OUTSIDE ITS STATED INTENDED USE IT MAY LEAD TO OUTCOMES THAT WERE NEVER INTENDED TO HAPPEN AND WERE NEVER STUDIED. THE DEVICE WAS USED OFF-LABEL FOR TREATMENT OF A PANCREATIC LEAK, INDWELL PERIOD OF STENTS THAT MIGRATED IS UNKNOWN, HOWEVER IT IS KNOWN THAT SOME GEENEN STENTS WERE LEFT IN-SITU FOR GREATER THAN THE RECOMMENDED 3 MONTHS, THIS COULD ALSO HAVE BEEN A CONTRIBUTING FACTOR IF THIS WAS THE CASE. IT MAY ALSO BE NOTED THAT AS PER THE INSTRUCTIONS FOR USE, MIGRATION IS A KNOWN POTENTIAL COMPLICATION. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ALL MIGRATED STENTS WERE TREATED ENDOSCOPICALLY, NO ADDITIONAL ADVERSE EVENTS WERE REPORTED TO THE PATIENT AS A RESULT OF DEVICE USE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.
INVESTIGATION IS IN PROGRESS.
SUPPLEMENTAL FOLLOW-UP REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 11-MAR-2021 AND AN UPDATE TO THE INVESTIGATION CONCLUSIONS. IT CAN BE NOTED ON FURTHER REVIEW OF THIS PAPER AND RECEIPT OF CLINICAL INPUT ON 25-FEB-2021 THE DESCRIPTION OF EVENT HAS BEEN UPDATED. UPDATED DESCRIPTION: "IN THREE PATIENTS A MIGRATION OF STENTS WAS OBSERVED. IN ONE CASE THE MIGRATION TOOK PLACE INTO THE LUMEN OF THE COLLECTION AND THE STENT WAS REMOVED WITH DORMIA BASKET, THIS HAS BEEN CONFIRMED AS THE ZSO STENT BY CLINICAL ADVISEMENT. THIS FILE WAS CREATED TO CAPTURE THE 2 STENT MIGRATIONS RELATED TO GEENEN PANCREATIC STENT. IT CANNOT BE CONFIRMED IF THE STENT MIGRATION OCCURRED WITH GEENEN, ZIMMON PANCREATIC STENT OR ZSO-10-5- THEREFORE SEPARATE FILES HAVE BEEN CREATED TO CAPTURE THE POTENTIAL OF EACH DEVICE. OFF LABEL USE FOR TREATMENT OF A PANCREATIC LEAK" INITIAL REPORT DETAILS: SMOCYNSKI 2013 ¿ENDOSCOPIC DRAINAGE/DEBRIDEMENT OF WALLED-OFF PANCREATIC NECROSIS - SINGLE CENTER EXPERIENCE OF 112 CASES¿ BETWEEN 2001 AND 2011 IN THE DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY OF THE MEDICAL UNIVERSITY OF GDANSK 112 PATIENTS WITH WON UNDERWENT ENDOSCOPIC TREATMENT. THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED IN 81 PATIENTS, THEN PANCREATIC SPHINCTEROTOMY WAS PERFORMED WITH THE USE OF OLYMPUS FLOWCUT KD-301Q0725 SPHINCTROTOME AND A 5-10 FR PANCREATIC ENDOPROSTHESIS (GEENEN OR ZIMMON PANCREATIC STENT, WILSON-COOK MEDICALINC.) WAS INTRODUCED INTO THE MAIN PANCREATIC DUCT. FISTULA WAS PERFORMED ON THE TOP OF THE LARGEST BULGE INTO THE GASTRIC OR DUODENAL WALL. WHEN THE BULGING WAS NOT VISIBLE THE FOLLOWING GUIDELINES WERE USED: TOPOGRAPHIC DATA OBTAINED FROM CECT, FLUOROSCOPIC IMAGE OF THE MAIN PANCREATIC DUCT LEAK OR THE FLOW OF CONTRAST MEDIUM ADMINISTERED THROUGH PERCUTANEOUS DRAIN AND OPACIFICATION OF THE COLLECTION WITH CONTRAST. THE ENTEROSTOMY WAS PERFORMED WITH A 7 FR FISTULOTOME (HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HPC-3, WILSON-COOK) OR A GIOVANNINI CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK). THE FLUID SAMPLE WAS OBTAINED FROM THE COLLECTION TO ASSESS AMYLASE ACTIVITY AND MICROBIAL CULTURING. THE MORPHOLOGY OF THE ASPIRATE E DARK AND VISIBLE NECROTIC DEBRIS WAS USED AS NECROSIS INDICATOR. THE STOMA WAS WIDENED WITH THE USE OF ¿BOUGIE¿ TYPE CATHETERS (SOEHENDRA BILIARY DILATION CATHETERS SBDC-8.5, SBDC-10, WILSON-COOK) ALONE IN 60 PATIENTS AND WITH HIGH-PRESSURE BALLOONS OF 8 OR 20 MM IN DIAMETER (BOSTON SCIENTIFIC) - IN 33 PATIENTS (8 MM IN 15 PATIENTS AND 20 MM IN 18 PATIENTS). THROUGH THE FISTULA DRAINAGE SYSTEM WAS INSTALLED CONSISTING OF 10 FR ¿DOUBLE PIGTAIL¿ ENDOPROSTHESES (ZSO-10-5, WILSON COOK) AND 7 FR OR 8.5 FR NASOCYSTIC DRAINS (BALTON OR WILSON- COOK). IN THE CASES OF CLINICAL SUSPICION THAT THE SYSTEM DID NOT DRAIN THE WHOLE NECROTIC AREA, THE POSITIONING OF THE DRAIN WAS ALTERED, ANOTHER FISTULA WAS MADE IN A NEW LOCATION, OR THE DRAIN WAS INTRODUCED TRANSPAPILLARILY THROUGH THE MAIN PANCREATIC DUCT LEAK. WON WAS IRRIGATED WITH A VOLUME OF SALINE SOLUTION FITTED TO THE SIZE OF THE COLLECTION (60E200 ML). IN THE FIRST 48 H OF TREATMENT IRRIGATION WAS PERFORMED EVERY 2 H, IN THE SUBSEQUENT 48 H EVERY 4 H. ALL PATIENTS RECEIVED ANTIBIOTICS (CIPROFLOXACIN OR CEFTRIAXONE WITH METRONIDAZOLE) PRIOR TO THE PROCEDURE. ROUTINELY ANTIBIOTIC THERAPY WAS CONTINUED FOR 2 WEEKS. IN THREE PATIENTS A MIGRATION OF STENTS WAS OBSERVED. IN ONE CASE THE MIGRATION TOOK PLACE INTO THE LUMEN OF THE COLLECTION AND THE STENT WAS REMOVED WITH DORMIA BASKET. THIS FILE WAS CREATED TO CAPTURE THE 3 STENT MIGRATIONS RELATED TO GEENEN PANCREATIC STENT. THIS FILE IS ALSO RELATED TO OFF LABEL USE- TRANSGASTRIC AND TRANSDUODENAL STENT PLACEMENT THROUGH FISTULA INTO WON FLUID COLLECTION. IT CANNOT BE CONFIRMED IF THE STENT MIGRATION OCCURRED WITH GEENEN, ZIMMON PANCREATIC STENT OR ZSO-10-5- THEREFORE SEPARATE FILES HAVE BEEN CREATED TO CAPTURE THE POTENTIAL OF EACH DEVICE.
SUPPLEMENTAL REPORT BEING SUBMITTED AS DURING THE COURSE OF THE INVESTIGATION, THE NUMBER OF DEVICES BEING CAPTURED IN THIS COMPLAINT WAS UPDATED FROM 3 TO 2 GEENEN PANCREATIC STENT ON (B)(6) 2020. SMOCYNSKI 2013 ¿ENDOSCOPIC DRAINAGE/DEBRIDEMENT OF WALLED-OFF PANCREATIC NECROSIS - SINGLE CENTER EXPERIENCE OF (B)(4) CASES¿ BETWEEN 2001 AND 2011 IN THE DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY OF THE MEDICAL UNIVERSITY OF GDANSK 112 PATIENTS WITH WON UNDERWENT ENDOSCOPIC TREATMENT. THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED IN 81 PATIENTS, THEN PANCREATIC SPHINCTEROTOMY WAS PERFORMED WITH THE USE OF OLYMPUS FLOWCUT KD-301Q0725 SPHINCTROTOME AND A 5-10 FR PANCREATIC ENDOPROSTHESIS (GEENEN OR ZIMMON PANCREATIC STENT, WILSON-COOK MEDICALINC.) WAS INTRODUCED INTO THE MAIN PANCREATIC DUCT. FISTULA WAS PERFORMED ON THE TOP OF THE LARGEST BULGE INTO THE GASTRIC OR DUODENAL WALL. WHEN THE BULGING WAS NOT VISIBLE THE FOLLOWING GUIDELINES WERE USED: TOPOGRAPHIC DATA OBTAINED FROM CECT, FLUOROSCOPIC IMAGE OF THE MAIN PANCREATIC DUCT LEAK OR THE FLOW OF CONTRAST MEDIUM ADMINISTERED THROUGH PERCUTANEOUS DRAIN AND OPACIFICATION OF THE COLLECTION WITH CONTRAST. THE ENTEROSTOMY WAS PERFORMED WITH A 7 FR FISTULOTOME (HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HPC-3, WILSON-COOK) OR A GIOVANNINI CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK). THE FLUID SAMPLE WAS OBTAINED FROM THE COLLECTION TO ASSESS AMYLASE ACTIVITY AND MICROBIAL CULTURING. THE MORPHOLOGY OF THE ASPIRATE E DARK AND VISIBLE NECROTIC DEBRIS WAS USED AS NECROSIS INDICATOR. THE STOMA WAS WIDENED WITH THE USE OF ¿BOUGIE¿ TYPE CATHETERS (SOEHENDRA BILIARY DILATION CATHETERS SBDC-8.5, SBDC-10, WILSON-COOK) ALONE IN 60 PATIENTS AND WITH HIGH-PRESSURE BALLOONS OF 8 OR 20 MM IN DIAMETER (BOSTON SCIENTIFIC) - IN 33 PATIENTS (8 MM IN 15 PATIENTS AND 20 MM IN 18 PATIENTS). THROUGH THE FISTULA DRAINAGE SYSTEM WAS INSTALLED CONSISTING OF 10 FR ¿DOUBLE PIGTAIL¿ ENDOPROSTHESES (ZSO-10-5, WILSON COOK) AND 7 FR OR 8.5 FR NASOCYSTIC DRAINS (BALTON OR WILSON- COOK). IN THE CASES OF CLINICAL SUSPICION THAT THE SYSTEM DID NOT DRAIN THE WHOLE NECROTIC AREA, THE POSITIONING OF THE DRAIN WAS ALTERED, ANOTHER FISTULA WAS MADE IN A NEW LOCATION, OR THE DRAIN WAS INTRODUCED TRANSPAPILLARILY THROUGH THE MAIN PANCREATIC DUCT LEAK. WON WAS IRRIGATED WITH A VOLUME OF SALINE SOLUTION FITTED TO THE SIZE OF THE COLLECTION (60E200 ML). IN THE FIRST 48 H OF TREATMENT IRRIGATION WAS PERFORMED EVERY 2 H, IN THE SUBSEQUENT 48 H EVERY 4 H. ALL PATIENTS RECEIVED ANTIBIOTICS (CIPROFLOXACIN OR CEFTRIAXONE WITH METRONIDAZOLE) PRIOR TO THE PROCEDURE. ROUTINELY ANTIBIOTIC THERAPY WAS CONTINUED FOR 2 WEEKS. IN THREE PATIENTS A MIGRATION OF STENTS WAS OBSERVED. IN ONE CASE THE MIGRATION TOOK PLACE INTO THE LUMEN OF THE COLLECTION AND THE STENT WAS REMOVED WITH DORMIA BASKET. THIS FILE WAS CREATED TO CAPTURE THE 2 STENT MIGRATIONS RELATED TO GEENEN PANCREATIC STENT. THIS FILE IS ALSO RELATED TO OFF LABEL USE- TRANSGASTRIC AND TRANSDUODENAL STENT PLACEMENT THROUGH FISTULA INTO WON FLUID COLLECTION. IT CANNOT BE CONFIRMED IF THE STENT MIGRATION OCCURRED WITH GEENEN, ZIMMON PANCREATIC STENT OR ZSO-10-5- THEREFORE SEPARATE FILES HAVE BEEN CREATED TO CAPTURE THE POTENTIAL OF EACH DEVICE.
INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
SMOCYNSKI 2013 ¿ENDOSCOPIC DRAINAGE/DEBRIDEMENT OF WALLED-OFF PANCREATIC NECROSIS - SINGLE CENTER EXPERIENCE OF 112 CASES¿. BETWEEN 2001 AND 2011 IN THE DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY OF THE MEDICAL UNIVERSITY OF GDANSK 112 PATIENTS WITH WON UNDERWENT ENDOSCOPIC TREATMENT. THE MAIN PANCREATIC DUCT LEAK WAS OBSERVED IN 81 PATIENTS, THEN PANCREATIC SPHINCTEROTOMY WAS PERFORMED WITH THE USE OF OLYMPUS FLOWCUT KD-301Q0725 SPHINCTROTOME AND A 5-10 FR PANCREATIC ENDOPROSTHESIS (GEENEN OR ZIMMON PANCREATIC STENT, WILSON-COOK MEDICALINC.) WAS INTRODUCED INTO THE MAIN PANCREATIC DUCT. FISTULA WAS PERFORMED ON THE TOP OF THE LARGEST BULGE INTO THE GASTRIC OR DUODENAL WALL. WHEN THE BULGING WAS NOT VISIBLE THE FOLLOWING GUIDELINES WERE USED: TOPOGRAPHIC DATA OBTAINED FROM CECT, FLUOROSCOPIC IMAGE OF THE MAIN PANCREATIC DUCT LEAK OR THE FLOW OF CONTRAST MEDIUM ADMINISTERED THROUGH PERCUTANEOUS DRAIN AND OPACIFICATION OF THE COLLECTION WITH CONTRAST. THE ENTEROSTOMY WAS PERFORMED WITH A 7 FR FISTULOTOME (HUIBREGTSE TRIPLE LUMEN NEEDLE KNIFE HPC-3, WILSON-COOK) OR A GIOVANNINI CYSTOTOME (CYSTOTOME CST-10, WILSON-COOK). THE FLUID SAMPLE WAS OBTAINED FROM THE COLLECTION TO ASSESS AMYLASE ACTIVITY AND MICROBIAL CULTURING. THE MORPHOLOGY OF THE ASPIRATE E DARK AND VISIBLE NECROTIC DEBRIS WAS USED AS NECROSIS INDICATOR. THE STOMA WAS WIDENED WITH THE USE OF ¿BOUGIE¿ TYPE CATHETERS (SOEHENDRA BILIARY DILATION CATHETERS SBDC-8.5, SBDC-10, WILSON-COOK) ALONE IN 60 PATIENTS AND WITH HIGH-PRESSURE BALLOONS OF 8 OR 20 MM IN DIAMETER (BOSTON SCIENTIFIC) - IN 33 PATIENTS (8 MM IN 15 PATIENTS AND 20 MM IN 18 PATIENTS). THROUGH THE FISTULA DRAINAGE SYSTEM WAS INSTALLED CONSISTING OF 10 FR ¿DOUBLE PIGTAIL¿ ENDOPROSTHESES (ZSO-10-5, WILSON COOK) AND 7 FR OR 8.5 FR NASOCYSTIC DRAINS (BALTON OR WILSON- COOK). IN THE CASES OF CLINICAL SUSPICION THAT THE SYSTEM DID NOT DRAIN THE WHOLE NECROTIC AREA, THE POSITIONING OF THE DRAIN WAS ALTERED, ANOTHER FISTULA WAS MADE IN A NEW LOCATION, OR THE DRAIN WAS INTRODUCED TRANSPAPILLARILY THROUGH THE MAIN PANCREATIC DUCT LEAK. WON WAS IRRIGATED WITH A VOLUME OF SALINE SOLUTION FITTED TO THE SIZE OF THE COLLECTION (60E200 ML). IN THE FIRST 48 H OF TREATMENT IRRIGATION WAS PERFORMED EVERY 2 H, IN THE SUBSEQUENT 48 H EVERY 4 H. ALL PATIENTS RECEIVED ANTIBIOTICS (CIPROFLOXACIN OR CEFTRIAXONE WITH METRONIDAZOLE) PRIOR TO THE PROCEDURE. ROUTINELY ANTIBIOTIC THERAPY WAS CONTINUED FOR 2 WEEKS. IN THREE PATIENTS A MIGRATION OF STENTS WAS OBSERVED. IN ONE CASE THE MIGRATION TOOK PLACE INTO THE LUMEN OF THE COLLECTION AND THE STENT WAS REMOVED WITH DORMIA BASKET. THIS FILE WAS CREATED TO CAPTURE THE 3 STENT MIGRATIONS RELATED TO GEENEN PANCREATIC STENT. THIS FILE IS ALSO RELATED TO OFF LABEL USE- TRANSGASTRIC AND TRANSDUODENAL STENT PLACEMENT THROUGH FISTULA INTO WON FLUID COLLECTION. IT CANNOT BE CONFIRMED IF THE STENT MIGRATION OCCURRED WITH GEENEN, ZIMMON PANCREATIC STENT OR ZSO-10-5- THEREFORE SEPARATE FILES HAVE BEEN CREATED TO CAPTURE THE POTENTIAL OF EACH DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1076409 | GEENEN PANCREATIC STENT | FGE CATHETER, BILIARY, DIAGNOSTIC | FGE | COOK IRELAND LTD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |