BIODESIGN HERNIA GRAFT
Report
- Report Number
- 1835959-2024-00002
- Event Type
- Death
- Date Received
- April 18, 2024
- Date of Event
- February 13, 2024
- Report Date
- May 3, 2024
- Manufacturer
- COOK BIOTECH
- Product Code
- OXK
- UDI-DI
- 10827002360324
- PMA / PMN Number
- K133306
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
THE INVESTIGATION INTO THIS OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED AS CBI BECOMES AWARE OF ADDITIONAL PERTINENT DETAILS.
RELATED TO MDR 1835959-2024-00003. SUMMARY OF INVESTIGATION FINDINGS: LB1533580 - REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THERE WERE NO NONCONFORMANCES. THE LOT PRODUCED A TOTAL OF ONE (1) DEVICE. THE DEVICE RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATIONS AND STERILIZATION REQUIREMENTS. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. THE IFU NOTES POSSIBLE ADVERSE REACTIONS WITH THE USE OF ANY PROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO: ADHESION, BOWEL EROSION, FISTULA FORMATION, HEMATOMA, INFECTION, INFLAMMATION, PREMATURE DEGRADATION, RECURRENCE OF TISSUE DEFECT AND SEROMA FORMATION. COMPLICATIONS, SUCH AS DELAYED WOUND INFECTION, PREMATURE DEGRADATION, HERNIA RECURRENCE, BOWEL EROSION, AND THE NEED FOR RE-OPERATION, SHOULD BE REASONABLY EXPECTED IN PATIENTS WHO ARE CRITICALLY ILL OR WHO HAVE SEVERELY CONTAMINATED ABDOMENS. THE ROOT CAUSE OF THE PATIENT'S POST OP COMPLICATIONS IS INCONCLUSIVE. WHEN ADDITIONAL DETAILS ARE RECEIVED FROM THE COMPLAINANT, THE COMPLAINT WILL BE REOPENED AND UPDATED.
PATIENT: MOTHER OF COMPLAINANT. ON (B)(6) 2024, THE COMPLAINANT REPORTED (VIA TEAMS) AWARENESS OF A BIODESIGN DEVICE IMPLANTED IN A PATIENT WHO LATER SUCCUMBED TO COMPLICATIONS. ON (B)(6) 2024, CBI¿S PRODUCT SURVEILLANCE ANALYST, WHO WAS ON PTO FROM 03/25/2024 THROUGH 03/28/2024, VIEWED THE COMPLAINANT¿S MESSAGE AND RESPONDED. THE COMPLAINANT WOULD ARRANGE A VIDEO CALL FOR DISCUSSION OF THE FEEDBACK. ON (B)(6) 2024, THE COMPLAINANT AND CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE VIA VIDEO CALL. THE COMPLAINANT EXPLAINED THE DETAILS OF THE PATIENT¿S COURSE OF EVENTS AS THE PRODUCT SURVEILLANCE ANALYST TOOK NOTES. DURING THIS CALL, THE COMPLAINANT WAS TEARFUL AS THEY RECALLED THE PATIENT¿S COURSE OF EVENTS. THE COMPLAINANT EXPRESSED FEELING THERE SHOULD HAVE BEEN MORE DONE, BY THE HOSPITAL STAFF AND SURGEON, TO INTERVENE AND NOT RESULT IN THE DEATH OF THE PATIENT. ON (B)(6) 2024, THE COMPLAINANT AND CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE AGAIN VIA VIDEO CALL. THE POINT OF THIS DISCUSSION WAS TO REVIEW THE PRIOR DAY¿S NOTES AND EDIT AS NEEDED TO ENSURE ACCURACY IN THE TIMELINE OF EVENTS. ON (B)(6) 2024, CBI¿S QUALITY SYSTEMS MANAGER REVIEWED THE COMPLAINT DETAILS AND REQUESTED CLARITY ON A FEW ITEMS. LATER THAT DAY THE COMPLAINANT AND PRODUCT SURVEILLANCE ANALYST HAD A VIDEO CALL TO REVIEW THOSE ITEMS. THE TIMELINE OF EVENTS AND NOTES WERE UPDATED ACCORDINGLY. FROM THE (B)(6) 2024 VIDEO CALLS, THE FOLLOWING DETAILS WERE OBTAINED: SALES REPRESENTATIVE ¿ (B)(4). - (B)(4) DELIVERED THE PRODUCT TO THE HOSPITAL. THE COMPLAINANT WAS UNCERTAIN IF (B)(4) WAS PRESENT IN THE OPERATING ROOM, DURING THE SURGICAL PROCEDURE. PATIENT: 86-YEAR-OLD FEMALE. RELEVANT/KNOWN PATIENT HISTORY: ATRIAL FIBRILLATION; AT HOME OXYGEN USE AT 4 LITERS PER MINUTE SINCE APRIL 2021; RAPID DECREASE IN OXYGEN SATURATION WHEN BREATHING ON ROOM AIR (NO SUPPLEMENTAL OXYGEN). DEVICE IMPLANT DATE: (B)(6) 2024. IMPLANT SURGEON: DR. (B)(6) . IMPLANT FACILITY: (B)(6) HOSPITAL. APPROXIMATELY 3 WEEKS PRIOR TO DEVICE PLACEMENT, THE PATIENT PRESENTED TO THE (B)(6) HOSPITAL EMERGENCY ROOM (ER) WITH LOWER RIGHT ABDOMINAL PAIN. THE COMPLAINANT DESCRIBED THE PATIENT¿S PAIN AS ¿EXCRUCIATING.¿ THE PATIENT WAS DIAGNOSED WITH A HERNIA WHICH WAS REDUCED (MANUAL PRESSURE APPLIED TO GUIDE THE HERNIA BACK THROUGH THE DEFECT) IN THE EMERGENCY ROOM. THE PATIENT WAS DISCHARGED HOME WITH AN ABDOMINAL BINDER AND ADVISED TO FOLLOW-UP WITH THEIR PHYSICIAN IN THREE (3) DAYS. UPON FOLLOW-UP WITH THE PATIENT¿S PHYSICIAN (FRANCES), HERNIA REPAIR SURGERY WAS RECOMMENDED. THE PATIENT¿S UNDERLYING CONDITIONS MADE THEM A CONSIDERABLE RISK FOR GENERAL ANESTHESIA AND THE PHYSICIAN INDICATED A BLOCK (E.G., EPIDURAL) COULD BE AN OPTION FOR ANESTHESIA. ON (B)(6) 2024, THE PATIENT UNDERWENT LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY UNDER GENERAL ANESTHESIA. A TOTAL OF 5 HERNIAS WERE DISCOVERED AND REPAIRED. PER COMPLAINANT¿S REVIEW OF THE OPERATIVE REPORT, A URINARY CATHETER WAS PLACED DURING SURGERY. THE SURGERY LASTED APPROXIMATELY 2 AND ½ HOURS AND THE SURGEON RELAYED NO SURGICAL COMPLICATIONS TO THE FAMILY. THE COMPLAINANT REJOINED THE PATIENT IN THE OUTPATIENT/RECOVERY AREA. PRIOR TO THE COMPLAINANT ARRIVING, THE PATIENT HAD AMBULATED WITH STAFF ASSISTANCE TO THE RESTROOM AND URINATED WITHOUT INCIDENT. UPON COMPLAINANT¿S ARRIVAL, THE PATIENT WAS GROGGY, BUT COHERENT. DURING THAT TIME, THE PATIENT NEEDED TO URINATE AGAIN. WHEN THE PATIENT AROSE FROM THE RECLINER, THE COMPLAINANT NOTICED LIGHT BLOOD SPOTTING ON THE PROTECTIVE COVERING ON THE RECLINER SEAT. THE PATIENT AMBULATED WITH STAFF ASSISTANCE TO THE RESTROOM. THE PATIENT URINATED IN THE TOILET. IT IS UNCERTAIN IF THERE WAS BLOOD IN THE EXPELLED URINE, BUT THE COMPLAINANT DID NOTICE BLOOD ON THE TOILET PAPER. THE PATIENT THEN WALKED, UNASSISTED TO THE SINK TO WASH THEIR HANDS. THE PATIENT THEN STOOD VERY STILL, WAS STIFF AS IF FROZEN IN PLACE AND BECAME VERY PALE WHITE IN COLOR. (THE COMPLAINANT STRONGLY BELIEVES THIS IS THE MOMENT THAT SOMETHING OCCURRED INTERNALLY THAT RESULTED IN THE INTERNAL BLEEDING DESCRIBED LATER AND WHICH IS LISTED AS A CAUSE OF DEATH.) MULTIPLE PEOPLE, INCLUDING THE PATIENT¿S FAMILY, SAFELY ASSISTED THE PATIENT INTO A CHAIR. THE PATIENT DID NOT FALL DURING THIS INCIDENT. THERE WERE NO OUTWARD INJURIES SUSTAINED FROM THE INCIDENT. HOWEVER, UPON THE PATIENT RETURNING TO THE RECLINER, THE FAMILY OBSERVED THE PATIENT HAD BEEN TAKEN TO THE RESTROOM WITHOUT THEIR SUPPLEMENTAL OXYGEN. AFTER THIS INCIDENT, THE COMPLAINANT OBSERVED THAT THE PATIENT¿S VITAL SIGNS WERE ERRATIC. DUE TO THIS INCIDENT, THE COMPLAINANT MADE NUMEROUS REQUESTS FOR THE PATIENT TO BE SEEN BY THEIR SURGEON TO ENSURE THE PATIENT¿S SAFETY. HOSPITAL STAFF CALLED THE SURGEON AT THE FAMILY¿S INSISTENCE. THE COMPLAINANT WAS EVENTUALLY TOLD THAT THE SURGEON WAS IN A SURGERY AND WOULD NOT BE AVAILABLE UNTIL LATER IN THE EVENING. THE PATIENT¿S VITAL SIGNS TOOK ABOUT 1 AND A ½ HOURS TO STABILIZE. THE PATIENT WAS NOT SEEN AFTER THIS INCIDENT BY A PHYSICIAN OR THEIR SURGEON PRIOR TO BEING DISCHARGED TO HOME THE SAME DAY. ON (B)(6) 2024, THE PATIENT REPORTED TO THE COMPLAINANT THAT THEY DID NOT FEEL WELL. THE PATIENT REPEATEDLY STATED, ¿SOMETHING¿S NOT RIGHT¿ WHILE HOLDING THEIR ABDOMEN. THE COMPLAINANT DESCRIBED THE PATIENT¿S COLOR AS PASTY AND THE PATIENT WAS WEAK. THE COMPLAINANT CONTACTED THE SURGEON AS THEY WERE CONCERNED ABOUT THE PATIENT¿S CONDITION. THE COMPLAINANT RECEIVED A RETURN CALL FROM THE ON-CALL DOCTOR, DR. (B)(6) . THE COMPLAINANT WAS INFORMED THAT THE PATIENT¿S POST-OP PROGRESS SEEMED TO BE AS EXPECTED. ON (B)(6) 2024 THE COMPLAINANT WAS STILL CONCERNED AS THE PATIENT CONTINUED TO COMPLAIN ¿SOMETHING¿S NOT RIGHT¿ WHILE HOLDING THEIR ABDOMEN. AT 5:54 AM (0554) THIS DAY, THE COMPLAINANT AGAIN CONTACTED THE SURGEON¿S OFFICE AND LEFT A MESSAGE. DR. (B)(6) RETURNED THE CALL AND REINFORCED THAT THE PATIENT WAS RECOVERING APPROPRIATELY FOR SOMEONE OF THAT AGE. ON (B)(6) 2024, AT 11:53 PM (2353) THE COMPLAINANT CALLED 911 DUE TO THE PATIENT¿S OXYGEN SATURATION DROPPING TO 80%. THE PARAMEDICS ARRIVED AND WERE ABLE TO RAISE THE PATIENT¿S OXYGEN SATURATION TO 84% AND INDICATED THE PATIENT WAS STABLE ENOUGH TO NOT REQUIRE TRANSPORT TO THE HOSPITAL. HOWEVER, UPON INSISTENCE FROM THE COMPLAINANT, THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE (B)(6) HOSPITAL EMERGENCY ROOM. A CT SCAN CONFIRMED FLUID IN THE PATIENT¿S ABDOMEN. LAB WORK REVEALED EXCEPTIONALLY LOW HEMOGLOBIN. A BLOOD TRANSFUSION WAS ADMINISTERED IN THE ER. THE COMPLAINANT AND PATIENT WERE INFORMED THAT THE PATIENT HAD A SMALL LEAK IN THE ABDOMEN. THE COMPLAINANT AND PATIENT WERE INFORMED, BY THE EMERGENCY ROOM PERSONNEL, THAT SURGERY WAS NOT INDICATED AT THAT TIME. THE PATIENT WAS ADMITTED AS AN INPATIENT. DURING THE PATIENT¿S EMERGENCY ROOM VISIT AND SUBSEQUENT ADMISSION, THE PATIENT RECEIVED 2-3 UNITS OF BLOOD TRANSFUSIONS. FROM THE TIME THE PATIENT WAS ADMITTED TO AN INPATIENT HOSPITAL ROOM TO THE TIME OF THE PATIENT¿S PASSING, THE PATIENT CONTINUED TO DECLINE. AT ONE POINT THE PATIENT WAS ON 84 LITERS OF OXYGEN PER MINUTE. THE PATIENT EXPRESSED BEING IN PAIN AND VERY ANXIOUS. THE PATIENT PASSED AWAY ON (B)(6) 2024 AT 5:44 PM (1744). AN AUTOPSY WAS NOT PERFORMED. THE COMPLAINANT REPORTED THE CAUSES OF DEATH ON THE PATIENT¿S DEATH CERTIFICATE WERE AS FOLLOWS: 1.) ACUTE ON CHRONIC RESPIRATORY FAILURE ¿ INTERVAL BETWEEN ONSET AND DEATH: 1 DAY. 2.) ACUTE BLOOD LOSS ANEMIA ¿ INTERVAL BETWEEN ONSET AND DEATH: 2 DAYS. 3.) LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY ¿ INTERVAL BETWEEN ONSET AND DEATH: 4 DAYS. THE COMPLAINANT AGREED TO PROVIDE THE OPERATIVE REPORT AND RPN TO THE PRODUCT SURVEILLANCE ANALYST. ONCE THAT IS RECEIVED AND REVIEWED, THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. AT THE CONCLUSION OF THE (B)(6) 2024 VIDEO CALL, THE COMPLAINANT CONFIRMED ACCURACY OF THE COURSE OF EVENTS AS DOCUMENTED. ON (B)(6) 2024, THE PRODUCT SURVEILLANCE ANALYST CONTACTED ASSOCIATED SALES REPRESENTATIVE TO OBTAIN DEVICE IDENTIFIERS AND TO CLARIFY IF THEY WERE IN THE OPERATING ROOM DURING THE OPERATION. THE DEVICES IMPLANTED IN THE PATIENT WERE A BIODESIGN HERNIA GRAFT C-SLH-8H-13X15 LB1533580 AND A BIODESIGN HERNIA GRAFT C-SLH-8H-13X22 LB1536538. THE SALES REPRESENTATIVE REPORTED BEING PRESENT IN THE OPERATING ROOM DURING THE SURGICAL PROCEDURE. THE SALES REPRESENTATIVE ALSO CONFIRMED THEY WERE NO SURGICAL OR PATIENT COMPLICATIONS DURING THE SURGICAL PROCEDURE.
COMPLAINANT: CBI EMPLOYEE ¿ THROUGHOUT THE 04/01/2024 AND 04/02/2024 VIDEO CALLS, THE COMPLAINANT REFERRED/DEFERRED TO THEIR SIBLING FOR CLARITY/VERIFICATION OF THE DETAILS TO ENSURE ACCURACY. CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE ONLY TO THE COMPLAINANT DURING THE VIDEO CALLS. THE COMPLAINANT AND THEIR SIBLING COMMUNICATED VIA MESSAGING AS NEEDED. PATIENT: MOTHER OF COMPLAINANT ON 03/27/2024, THE COMPLAINANT REPORTED (VIA TEAMS) AWARENESS OF A BIODESIGN DEVICE IMPLANTED IN A PATIENT WHO LATER SUCCUMBED TO COMPLICATIONS. ON 03/29/2024, CBI¿S PRODUCT SURVEILLANCE ANALYST, WHO WAS ON PTO FROM 03/25/2024 THROUGH 03/28/2024, VIEWED THE COMPLAINANT¿S MESSAGE AND RESPONDED. THE COMPLAINANT WOULD ARRANGE A VIDEO CALL FOR DISCUSSION OF THE FEEDBACK. ON 04/01/2024, THE COMPLAINANT AND CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE VIA VIDEO CALL. THE COMPLAINANT EXPLAINED THE DETAILS OF THE PATIENT¿S COURSE OF EVENTS AS THE PRODUCT SURVEILLANCE ANALYST TOOK NOTES. DURING THIS CALL, THE COMPLAINANT WAS TEARFUL AS THEY RECALLED THE PATIENT¿S COURSE OF EVENTS. THE COMPLAINANT EXPRESSED FEELING THERE SHOULD HAVE BEEN MORE DONE, BY THE HOSPITAL STAFF AND SURGEON, TO INTERVENE AND NOT RESULT IN THE DEATH OF THE PATIENT. ON 04/02/2024, THE COMPLAINANT AND CBI¿S PRODUCT SURVEILLANCE ANALYST SPOKE AGAIN VIA VIDEO CALL. THE POINT OF THIS DISCUSSION WAS TO REVIEW THE PRIOR DAY¿S NOTES AND EDIT AS NEEDED TO ENSURE ACCURACY IN THE TIMELINE OF EVENTS. ON 04/04/2024, CBI¿S QUALITY SYSTEMS MANAGER REVIEWED THE COMPLAINT DETAILS AND REQUESTED CLARITY ON A FEW ITEMS. LATER THAT DAY THE COMPLAINANT AND PRODUCT SURVEILLANCE ANALYST HAD A VIDEO CALL TO REVIEW THOSE ITEMS. THE TIMELINE OF EVENTS AND NOTES WERE UPDATED ACCORDINGLY. FROM THE 04/01/2024, 04/02/2024 AND 04/04/2024 VIDEO CALLS, THE FOLLOWING DETAILS WERE OBTAINED: SALES REPRESENTATIVE ¿ KINSEY COBLE - KINSEY DELIVERED THE PRODUCT TO THE HOSPITAL. THE COMPLAINANT WAS UNCERTAIN IF KINSEY WAS PRESENT IN THE OPERATING ROOM, DURING THE SURGICAL PROCEDURE. PATIENT: 86-YEAR-OLD FEMALE RELEVANT/KNOWN PATIENT HISTORY: ATRIAL FIBRILLATION; AT HOME OXYGEN USE AT 4 LITERS PER MINUTE SINCE (B)(6) 2021; RAPID DECREASE IN OXYGEN SATURATION WHEN BREATHING ON ROOM AIR (NO SUPPLEMENTAL OXYGEN) DEVICE IMPLANT DATE: (B)(6) 2024 IMPLANT SURGEON: DR. (B)(6) IMPLANT FACILITY: (B)(6) HOSPITAL APPROXIMATELY 3 WEEKS PRIOR TO DEVICE PLACEMENT, THE PATIENT PRESENTED TO THE FRANCISCAN EAST HOSPITAL EMERGENCY ROOM (ER) WITH LOWER RIGHT ABDOMINAL PAIN. THE COMPLAINANT DESCRIBED THE PATIENT¿S PAIN AS ¿EXCRUCIATING.¿ THE PATIENT WAS DIAGNOSED WITH A HERNIA WHICH WAS REDUCED (MANUAL PRESSURE APPLIED TO GUIDE THE HERNIA BACK THROUGH THE DEFECT) IN THE ER. THE PATIENT WAS DISCHARGED HOME WITH AN ABDOMINAL BINDER AND ADVISED TO FOLLOW-UP WITH THEIR PHYSICIAN IN THREE (3) DAYS. UPON FOLLOW-UP WITH THE PATIENT¿S PHYSICIAN (FRANCES), HERNIA REPAIR SURGERY WAS RECOMMENDED. THE PATIENT¿S UNDERLYING CONDITIONS MADE THEM A CONSIDERABLE RISK FOR GENERAL ANESTHESIA AND THE PHYSICIAN INDICATED A BLOCK (E.G., EPIDURAL) COULD BE AN OPTION FOR ANESTHESIA. ON (B)(6) 2024, THE PATIENT UNDERWENT LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY UNDER GENERAL ANESTHESIA. A TOTAL OF 5 HERNIAS WERE DISCOVERED AND REPAIRED. PER COMPLAINANT¿S REVIEW OF THE OPERATIVE REPORT, A URINARY CATHETER WAS PLACED DURING SURGERY. THE SURGERY LASTED APPROXIMATELY 2 AND ½ HOURS AND THE SURGEON RELAYED NO SURGICAL COMPLICATIONS TO THE FAMILY. THE COMPLAINANT REJOINED THE PATIENT IN THE OUTPATIENT/RECOVERY AREA. PRIOR TO THE COMPLAINANT ARRIVING, THE PATIENT HAD AMBULATED WITH STAFF ASSISTANCE TO THE RESTROOM AND URINATED WITHOUT INCIDENT. UPON COMPLAINANT¿S ARRIVAL, THE PATIENT WAS GROGGY, BUT COHERENT. DURING THAT TIME, THE PATIENT NEEDED TO URINATE AGAIN. WHEN THE PATIENT AROSE FROM THE RECLINER, THE COMPLAINANT NOTICED LIGHT BLOOD SPOTTING ON THE PROTECTIVE COVERING ON THE RECLINER SEAT. THE PATIENT AMBULATED WITH STAFF ASSISTANCE TO THE RESTROOM. THE PATIENT URINATED IN THE TOILET. IT IS UNCERTAIN IF THERE WAS BLOOD IN THE EXPELLED URINE, BUT THE COMPLAINANT DID NOTICE BLOOD ON THE TOILET PAPER. THE PATIENT THEN WALKED, UNASSISTED TO THE SINK TO WASH THEIR HANDS. THE PATIENT THEN STOOD VERY STILL, WAS STIFF AS IF FROZEN IN PLACE AND BECAME VERY PALE WHITE IN COLOR. (THE COMPLAINANT STRONGLY BELIEVES THIS IS THE MOMENT THAT SOMETHING OCCURRED INTERNALLY THAT RESULTED IN THE INTERNAL BLEEDING DESCRIBED LATER AND WHICH IS LISTED AS A CAUSE OF DEATH.) MULTIPLE PEOPLE, INCLUDING THE PATIENT¿S FAMILY, SAFELY ASSISTED THE PATIENT INTO A CHAIR. THE PATIENT DID NOT FALL DURING THIS INCIDENT. THERE WERE NO OUTWARD INJURIES SUSTAINED FROM THE INCIDENT. HOWEVER, UPON THE PATIENT RETURNING TO THE RECLINER, THE FAMILY OBSERVED THE PATIENT HAD BEEN TAKEN TO THE RESTROOM WITHOUT THEIR SUPPLEMENTAL OXYGEN. AFTER THIS INCIDENT, THE COMPLAINANT OBSERVED THAT THE PATIENT¿S VITAL SIGNS WERE ERRATIC. DUE TO THIS INCIDENT, THE COMPLAINANT MADE NUMEROUS REQUESTS FOR THE PATIENT TO BE SEEN BY THEIR SURGEON TO ENSURE THE PATIENT¿S SAFETY. HOSPITAL STAFF CALLED THE SURGEON AT THE FAMILY¿S INSISTENCE. THE COMPLAINANT WAS EVENTUALLY TOLD THAT THE SURGEON WAS IN A SURGERY AND WOULD NOT BE AVAILABLE UNTIL LATER IN THE EVENING. THE PATIENT¿S VITAL SIGNS TOOK ABOUT 1 AND A ½ HOURS TO STABILIZE. THE PATIENT WAS NOT SEEN AFTER THIS INCIDENT BY A PHYSICIAN OR THEIR SURGEON PRIOR TO BEING DISCHARGED TO HOME THE SAME DAY. ON (B)(6) 2024, THE PATIENT REPORTED TO THE COMPLAINANT THAT THEY DID NOT FEEL WELL. THE PATIENT REPEATEDLY STATED, ¿SOMETHING¿S NOT RIGHT¿ WHILE HOLDING THEIR ABDOMEN. THE COMPLAINANT DESCRIBED THE PATIENT¿S COLOR AS PASTY AND THE PATIENT WAS WEAK. THE COMPLAINANT CONTACTED THE SURGEON AS THEY WERE CONCERNED ABOUT THE PATIENT¿S CONDITION. THE COMPLAINANT RECEIVED A RETURN CALL FROM THE ON-CALL DOCTOR, DR. CHRISTY STOLLER. THE COMPLAINANT WAS INFORMED THAT THE PATIENT¿S POST-OP PROGRESS SEEMED TO BE AS EXPECTED. ON 02/11/2024 THE COMPLAINANT WAS STILL CONCERNED AS THE PATIENT CONTINUED TO COMPLAIN ¿SOMETHING¿S NOT RIGHT¿ WHILE HOLDING THEIR ABDOMEN. AT 5:54 AM (0554) THIS DAY, THE COMPLAINANT AGAIN CONTACTED THE SURGEON¿S OFFICE AND LEFT A MESSAGE. DR. STOLLER RETURNED THE CALL AND REINFORCED THAT THE PATIENT WAS RECOVERING APPROPRIATELY FOR SOMEONE OF THAT AGE. ON 02/11/2024, AT 11:53 PM (2353) THE COMPLAINANT CALLED 911 DUE TO THE PATIENT¿S OXYGEN SATURATION DROPPING TO 80%. THE PARAMEDICS ARRIVED AND WERE ABLE TO RAISE THE PATIENT¿S OXYGEN SATURATION TO 84% AND INDICATED THE PATIENT WAS STABLE ENOUGH TO NOT REQUIRE TRANSPORT TO THE HOSPITAL. HOWEVER, UPON INSISTENCE FROM THE COMPLAINANT, THE PATIENT WAS TRANSPORTED BY AMBULANCE TO THE FRANCISCAN EAST HOSPITAL EMERGENCY ROOM. A CT SCAN CONFIRMED FLUID IN THE PATIENT¿S ABDOMEN. LAB WORK REVEALED EXCEPTIONALLY LOW HEMOGLOBIN. A BLOOD TRANSFUSION WAS ADMINISTERED IN THE ER. THE COMPLAINANT AND PATIENT WERE INFORMED THAT THE PATIENT HAD A SMALL LEAK IN THE ABDOMEN. THE COMPLAINANT AND PATIENT WERE INFORMED, BY THE ER PERSONNEL, THAT SURGERY WAS NOT INDICATED AT THAT TIME. THE PATIENT WAS ADMITTED AS AN INPATIENT. DURING THE PATIENT¿S ER VISIT AND SUBSEQUENT ADMISSION, THE PATIENT RECEIVED 2-3 UNITS OF BLOOD TRANSFUSIONS. FROM THE TIME THE PATIENT WAS ADMITTED TO AN INPATIENT HOSPITAL ROOM TO THE TIME OF THE PATIENT¿S PASSING, THE PATIENT CONTINUED TO DECLINE. AT ONE POINT THE PATIENT WAS ON 84 LITERS OF OXYGEN PER MINUTE. THE PATIENT EXPRESSED BEING IN PAIN AND VERY ANXIOUS. THE PATIENT PASSED AWAY ON (B)(6) 2024 AT 5:44 PM (1744). AN AUTOPSY WAS NOT PERFORMED. THE COMPLAINANT REPORTED THE CAUSES OF DEATH ON THE PATIENT¿S DEATH CERTIFICATE WERE AS FOLLOWS: 1.) ACUTE ON CHRONIC RESPIRATORY FAILURE ¿ INTERVAL BETWEEN ONSET AND DEATH: 1 DAY 2.) ACUTE BLOOD LOSS ANEMIA ¿ INTERVAL BETWEEN ONSET AND DEATH: 2 DAYS 3.) LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY ¿ INTERVAL BETWEEN ONSET AND DEATH: 4 DAYS. THE COMPLAINANT AGREED TO PROVIDE THE OPERATIVE REPORT AND RPN TO THE PRODUCT SURVEILLANCE ANALYST. ONCE THAT IS RECEIVED AND REVIEWED, THE COMPLAINT FILE WILL BE UPDATED ACCORDINGLY. AT THE CONCLUSION OF THE 04/04/2024 VIDEO CALL, THE COMPLAINANT CONFIRMED ACCURACY OF THE COURSE OF EVENTS AS DOCUMENTED. ON 04/04/2024, THE PRODUCT SURVEILLANCE ANALYST CONTACTED ASSOCIATED SALES REPRESENTATIVE TO OBTAIN DEVICE IDENTIFIERS AND TO CLARIFY IF THEY WERE IN THE OPERATING ROOM DURING THE OPERATION. THE DEVICES IMPLANTED IN THE PATIENT WERE A BIODESIGN HERNIA GRAFT C-SLH-8H-13X15 LB1533580 AND A BIODESIGN HERNIA GRAFT C-SLH-8H-13X22 LB1536538. THE SALES REPRESENTATIVE REPORTED BEING PRESENT IN THE OPERATING ROOM DURING THE SURGICAL PROCEDURE. THE SALES REPRESENTATIVE ALSO CONFIRMED THEY WERE NO SURGICAL OR PATIENT COMPLICATIONS DURING THE SURGICAL PROCEDURE. UPDATE: ON 04/22/2024, THE COMPLAINANT INDICATED MEDICAL RECORDS WOULD NOT BE AVAILABLE FOR A FEW MORE WEEKS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2269765 | BIODESIGN HERNIA GRAFT | HERNIA GRAFT | OXK | COOK BIOTECH | LB1533580 | 10827002360324 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Death | C-SLH-8H-13X22 G46600 LB1536538 |