PERFORMER INTRODUCER
Report
- Report Number
- 1820334-2019-02908
- Event Type
- Death
- Date Received
- November 18, 2019
- Date of Event
- October 31, 2019
- Report Date
- March 20, 2020
- Manufacturer
- COOK INC
- Product Code
- DYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
INITIAL REPORT AS REPORTED, DURING A FENESTRATED ENDOVASCULAR AORTIC ANEURYSM REPAIR (FEVAR) PROCEDURE, THE HUB OF A PERFORMER INTRODUCER LEAKED. ACCESS WAS OBTAINED WITH DIFFICULTY IN A HEAVILY CALCIFIED, 4-5.5 MILLIMETER COMMON FEMORAL ARTERY. AS THE PATIENT'S ANATOMY WAS REPORTED TO BE NARROW AND HEAVILY CALCIFIED, THE PHYSICIAN PRE-TREATED THE EXTERNAL ILIAC ARTERIES WITH TWO 8 MILLIMETER STENT GRAFTS (OTHER MANUFACTURER). DILATORS WERE USED, UP TO 16 FRENCH, PRIOR TO INSERTING THE COMPLAINT DEVICE. THE USER REPORTEDLY HAD TO USE THE 18 FRENCH COMPLAINT DEVICE BECAUSE A 20 FRENCH SHEATH WAS NOT ABLE TO BE INSERTED INTO THE PATIENT'S ANATOMY. TWO 6 FRENCH HIGH-FLEX ANSEL SHEATHS AND ANOTHER MANUFACTURER'S CATHETER WERE PLACED INSIDE THE SHEATH. AFTER THE 6 FRENCH SHEATHS WERE INSERTED THROUGH THE SILICONE VALVE OF THE COMPLAINT DEVICE, THE VALVE/HUB LEAKED. REPORTEDLY, THE PATIENT LOST 1.25 LITERS OF BLOOD, PRIMARILY THROUGH THE SHEATH, WHICH WAS IN PLACE FOR APPROXIMATELY THREE-TO-FOUR HOURS. THE PATIENT DEVELOPED COAGULOPATHIC "ISSUES", A RETROPERITONEAL HEMORRHAGE, AND AN INTESTINAL INFARCT. THE PATIENT RECEIVED SEVERAL UNITS OF BLOOD AS WELL AS CELL-SAVER DURING THE PROCEDURE. THE PHYSICIAN ALSO RESECTED A PORTION OF THE INTESTINE. THE PHYSICIAN REPORTED A GOOD TECHNICAL RESULT IN PLACING THE COOK ZFEN GRAFT; HOWEVER, THE PATIENT DIED. THE PHYSICIAN HAS REPORTEDLY ATTRIBUTED THE PATIENT'S INABILITY TO SURVIVE THE EVENTS TO BLOOD LOSS. INVESTIGATION - EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWINGS, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL PROCEDURES, TRENDS, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS ONE NOTED NONCONFORMANCE FOR LEAKAGE WITHIN THE SHEATH SUBASSEMBLY. WHILE THIS NONCONFORMANCE IS POTENTIALLY RELATED TO THE REPORTED FAILURE, IT SHOULD BE NOTED THAT THE AFFECTED UNITS WERE SCRAPPED AND NOT REPLACED PRIOR TO ORDER COMPLETION. A REVIEW OF COMPLAINT HISTORY SHOWED NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE SPECIFICATIONS, DRAWINGS, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE ALSO CONDUCTED, AND NO GAPS WERE DISCOVERED. THE INFORMATION PROVIDED UPON REVIEW OF THE COMPLAINT FILE PROVIDES EVIDENCE TO SUPPORT THAT THE DEVICE AND ITEMS IN THE LOT WERE MANUFACTURED TO SPECIFICATION. THE INSTRUCTIONS FOR USE PACKAGED WITH THE DEVICE DOES NOT PROVIDE INFORMATION REGARDING PUNCTURING THE CHECK-FLO VALVE WITH A NEEDLE TO INTRODUCE ADDITIONAL DEVICES THROUGH THE SHEATH. THE IFU DOES, HOWEVER, PROVIDE THE PRECAUTION, ¿THIS PRODUCT IS INTENDED FOR USE BY PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD TECHNIQUES FOR PLACEMENT OF VASCULAR ACCESS SHEATHS SHOULD BE EMPLOYED." THE IFU FURTHER NOTES, "THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE ITS PASSAGE THROUGH THE INTRODUCER. ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT." BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS EVENT CAN BE TRACED TO A COMPONENT FAILURE INVOLVING THE HEMOSTASIS VALVE OF THE PERFORMANCE INTRODUCER. IN ACCORDANCE WITH COOK¿S MANAGEMENT SYSTEM, SPECIFICALLY RISK MANAGEMENT PROCEDURES, NO ADDITIONAL RISK MITIGATION ACTIVITIES ARE REQUIRED OR RECOMMENDED AT THIS TIME. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS: ICAST STENT (6MM X 22MM) IN RENAL ARTERY; STENT (ATRIUM 7MM X 22MM) IN SMA. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
ADDITIONAL INFORMATION WAS DISCOVERED 25FEB2020 THROUGH THE MAUDE DATABASE, REPORT (B)(4), NOTING THE FOLLOWING: "THE SHEATH WAS USED IN AN OFF-LABEL FASHION, WHICH IS TYPICAL, TO FACILITATE STENTING OF MULTIPLE VISCERAL VESSELS SIMULTANEOUSLY. THE MULTIPLE PUNCTURES ALLOW FOR LEAKAGE, AT A SLOW RATE, AROUND THE PUNCTURE SITES IN THE VALVE LEAFLETS, AS OPPOSED TO VALVE ORIFICE. IN THIS CASE, THE 18 FR. SHEATH MAY HAVE CONTRIBUTED TO THE PATIENT'S BLOOD LOSS."
ADDITIONAL INFORMATION WAS PROVIDED STATING THAT A COOK REPRESENTATIVE WAS PRESENT DURING THE CASE ASSOCIATED WITH THIS EVENT AND WAS NOTIFIED OF THE PATIENT¿S DEATH THE FOLLOWING DAY. IT WAS KNOWN IN ADVANCE THAT ACCESS MIGHT HAVE BEEN DIFFICULT DUE TO SMALL VESSEL SIZE AND CALCIFICATION. THE HEMOSTATIC VALVE WAS PUNCTURED MULTIPLE TIMES IN ORDER TO USE MULTIPLE DEVICES SIMULTANEOUSLY. BLOOD LOSS WAS OBSERVED EARLY IN THE PROCEDURE AND WAS REPORTEDLY DRIPPING FAST, ALTHOUGH IT WAS NOT A STEADY STREAM. AFTER A GOOD TECHNICAL PLACEMENT OF THE FENESTRATED GRAFT, THE PHYSICIAN NOTICED THAT FLOW WAS REDUCED TO THE SUPERIOR MESENTERIC ARTERY (SMA) AS WELL AS AN AREA OF INFARCTED INTESTINE. ALTHOUGH THE BLOOD LOSS FROM THE VALVE WAS OBSERVED, THE SMA WAS CANNULATED AND ANOTHER MANUFACTURER'S 7X22 STENT WAS PLACED. THE FELLOW INVOLVED IN THE PROCEDURE REPORTED THAT A POSSIBLE DISSECTION OF A SMA SIDE-BRANCH OCCURRED, RESULTING IN INTERNAL BLEEDING AND CONTRIBUTING TO TOTAL BLOOD LOSS. AFTER PLACEMENT OF THE SMA STENT, THE PHYSICIAN PROCEEDED TO PLACE ANOTHER MANUFACTURER'S 6X22 STENT IN THE LEFT RENAL ARTERY BECAUSE HE FELT THE ARTERY WAS NOT FULLY PATENT. PLACEMENT OF THE SMA STENT ADDED APPROXIMATELY 60 MINUTES TO THE PROCEDURE AND PLACEMENT OF THE RENAL STENT ADDED APPROXIMATELY 45 MINUTES TO THE PROCEDURE. THE TOTAL LENGTH OF THE PROCEDURE WAS NOTED TO BE APPROXIMATELY 5-6 HOURS. THE PROCEDURE WAS CONDUCTED IN THE CATHETERIZATION LAB ON A SEPARATE FLOOR FROM THE MAIN SURGICAL AREA, REQUIRING SOMEONE TO RUN BETWEEN FLOORS TO OBTAIN SUPPLIES. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.
CONCOMITANT PRODUCTS: ANGIODYNAMICS OMNI FLUSH CATHETER, GORE VIABAHN STENT GRAFTS (2), COOK 6 FRENCH HIGH-FLEX ANSEL SHEATHS (2), COOK Z-FEN STENT GRAFT. PMA/510(K) NUMBER: PRE-AMENDMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
AS REPORTED, DURING A FENESTRATED ENDOVASCULAR AORTIC ANEURYSM REPAIR (FEVAR) PROCEDURE, THE HUB OF A PERFORMER INTRODUCER LEAKED. ACCESS WAS OBTAINED WITH DIFFICULTY IN A HEAVILY CALCIFIED, 4-5.5 MILLIMETER COMMON FEMORAL ARTERY. AS THE PATIENT'S ANATOMY WAS REPORTED TO BE NARROW AND HEAVILY CALCIFIED, THE PHYSICIAN PRE-TREATED THE EXTERNAL ILIAC ARTERIES WITH TWO 8 MILLIMETER STENT GRAFTS (OTHER MANUFACTURER). DILATORS WERE USED, UP TO 16 FRENCH, PRIOR TO INSERTING THE COMPLAINT DEVICE. THE USER REPORTEDLY HAD TO USE THE 18 FRENCH COMPLAINT DEVICE BECAUSE A 20 FRENCH SHEATH WAS NOT ABLE TO BE INSERTED INTO THE PATIENT'S ANATOMY. TWO 6 FRENCH HIGH-FLEX ANSEL SHEATHS AND ANOTHER MANUFACTURER'S CATHETER WERE PLACED INSIDE THE SHEATH. AFTER THE 6 FRENCH SHEATHS WERE INSERTED THROUGH THE SILICONE VALVE OF THE COMPLAINT DEVICE, THE VALVE / HUB LEAKED. REPORTEDLY, THE PATIENT LOST 1.25 LITERS OF BLOOD, PRIMARILY THROUGH THE SHEATH, WHICH WAS IN PLACE FOR APPROXIMATELY THREE-TO-FOUR HOURS. THE PATIENT DEVELOPED COAGULOPATHIC "ISSUES", A RETROPERITONEAL HEMORRHAGE, AND AN INTESTINAL INFARCT. THE PATIENT RECEIVED SEVERAL UNITS OF BLOOD AS WELL AS CELL-SAVER DURING THE PROCEDURE. THE PHYSICIAN ALSO RESECTED A PORTION OF THE INTESTINE. THE PHYSICIAN REPORTED A GOOD TECHNICAL RESULT IN PLACING THE COOK ZFEN GRAFT; HOWEVER, THE PATIENT DIED. THE PHYSICIAN HAS REPORTEDLY ATTRIBUTED THE PATIENT'S INABILITY TO SURVIVE THE EVENTS TO BLOOD LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1133683 | PERFORMER INTRODUCER | DYB INTRODUCER, CATHETER | DYB | COOK INC | 9935834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death| R | SEE H10| SEE H10 |