ABSORBABLE GELATIN
Report
- Report Number
- 1810189-2023-00017
- Event Type
- Death
- Date Received
- April 20, 2023
- Report Date
- April 12, 2023
- Manufacturer
- PFIZER, INC.
- Product Code
- LMF
- PMA / PMN Number
- 18-286
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EVENT VERBATIM [PREFERRED TERM]. MULTIORGAN FAILURE [MULTIPLE ORGAN DYSFUNCTION SYNDROME], PERSISTENT POOR NEUROLOGICAL RECOVERY [NERVOUS SYSTEM DISORDER], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "UNUSUAL CASE OF DELAYED RUPTURE OF PANCREATIC NEUROENDOCRINE TUMOR AFTER ENDOSCOPIC ULTRASOUND AND BIOPSY", PANCREAS, 2022; VOL:51 (5), PGS:E79-E80. A 79-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HAEMOSTASIS. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "PANCREATIC NEUROENDOCRINE TUMOR (PNET)" (UNSPECIFIED IF ONGOING); "CRAMPY EPIGASTRIC PAIN" (UNSPECIFIED IF ONGOING); "HYPOTENSIVE" (UNSPECIFIED IF ONGOING); "DROWSINESS" (UNSPECIFIED IF ONGOING); "ABDOMINAL DISTENSION" (UNSPECIFIED IF ONGOING); "METABOLIC ACIDOSIS" (UNSPECIFIED IF ONGOING); "PERCUTANEOUS ANGIOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "EXPLORATORY LAPAROTOMY" (UNSPECIFIED IF ONGOING); "PANCREATOSPLENECTOMY" (UNSPECIFIED IF ONGOING); "BILATERAL PULMONARY EMBOLISM" (UNSPECIFIED IF ONGOING); "PANCREATIC-NECK, THICK-WALLED CYST" (UNSPECIFIED IF ONGOING), NOTES: WITH MILD PANCREATIC DUCT DILATATION, EUS AND FNA WERE PERFORMED; "PNET WAS NOTED TO HAVE RUPTURED" (UNSPECIFIED IF ONGOING). THE PATIENT TOOK CONCOMITANT MEDICATIONS. THE FOLLOWING INFORMATION WAS REPORTED: MULTIPLE ORGAN DYSFUNCTION SYNDROME (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "MULTIORGAN FAILURE"; NERVOUS SYSTEM DISORDER (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "PERSISTENT POOR NEUROLOGICAL RECOVERY". THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "MULTIORGAN FAILURE", "PERSISTENT POOR NEUROLOGICAL RECOVERY". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: WE REPORT A RARE CASE OF PNET WITH POSSIBLE DELAYED IATROGENIC RUPTURE 2MONTHS AFTER EUS AND FNA. OUR PATIENT WITH A PANCREATIC NECK PNET INCIDENTALLY DISCOVERED AS A CYST WITH SOLID COMPONENT DURING HER ROUTINE ABDOMINAL ULTRASOUND FOR HEPATITIS B FOLLOW-UP. A CT OF HER PANCREAS WAS PERFORMED, WHICH FURTHER CHARACTERIZED THE LESION AS A 3.4-CM PANCREATIC-NECK, THICK-WALLED CYST WITH MILD PANCREATIC DUCT DILATATION. AN EUS AND FNA WERE PERFORMED USING A 19-GAUGE NEEDLE, REQUIRING MULTIPLE PASSES. HISTOLOGY YIELDED WELL-DIFFERENTIATED NEUROENDOCRINE CELLS. SHE WAS PLANNED FOR SURGERY PENDING CARDIAC WORKUP AS SHE ALSO RECENTLY UNDERWENT AN AORTIC VALVE REPLACEMENT HALF A YEAR PRIOR, WITH RECOVERY COMPLICATED BY COMPLETE HEART BLOCK NEEDING INSERTION OF PERMANENT PACEMAKER, AS WELL AS BILATERAL PULMONARY EMBOLISM REQUIRING LIFELONG ANTICOAGULATION. SHE PRESENTED 2 MONTHS AFTER FNA WITH A WEEK HISTORY OF CRAMPY EPIGASTRIC PAIN WITH NEITHER OTHER GASTROINTESTINAL SYMPTOMS NOR FEVER. A CT PERFORMED REVEALED THAT HER PNET HAS GROWN TO 4.9 CM, WITH RUPTURE AND HEMORRHAGE TO THE PERIPANCREATIC AND PERIGASTRIC REGIONS. UPON ADMISSION, SHE QUICKLY BECAME HYPOTENSIVE, AND AN URGENT CT MESENTERIC ANGIOGRAM REVEALED ACTIVE CONTRAST EXTRAVASATION INTO THE PANCREATIC MASS VIA A SMALL BRANCH OF THE PANCREATICODUODENAL ARTERY. INITIAL TREATMENT WITH PERCUTANEOUS ANGIOEMBOLIZATION WAS ATTEMPTED, BUT AS OUR PATIENT REMAINED PERSISTENTLY HYPOTENSIVE WITH WORSENING DROWSINESS, ABDOMINAL DISTENSION, AND METABOLIC ACIDOSIS, THE DECISION WAS HENCE MADE FOR EXPLORATORY LAPAROTOMY. INTRAOPERATIVELY, MASSIVE BLEEDING OF UP TO 15 L WAS ENCOUNTERED REQUIRING MASSIVE TRANSFUSION. THE PNET WAS NOTED TO HAVE RUPTURED AND INVOLVED THE MAIN BRANCHES OF THE SUPERIORMESENTERIC VEIN. CLOT EVACUATION, ADHESIOLYSIS, AND SUBTOTAL PANCREATOSPLENECTOMY WERE PERFORMED WITH TEMPORARY CLOSURE. THE PATIENT WAS STABILIZED IN THE INTENSIVE CARE UNIT OVERNIGHT BEFORE A RELOOK LAPAROTOMY, HEMOSTASIS, AND SECONDARY CLOSURE WERE PERFORMED THE FOLLOWING DAY. HISTOLOGY REVEALED A WELL-DIFFERENTIATED PNET WITH LYMPHOVASCULAR INVASION AND NEGATIVE RESECTION MARGINS. ALTHOUGH OUR PATIENT WAS ABLE TO BE WEANED OFF INOTROPES INITIALLY POSTOPERATIVELY, SHE SUBSEQUENTLY DEVELOPED POSTOPERATIVE PANCREATIC FISTULA, WITH CT DEMONSTRATING A GALLBLADDER FOSSA COLLECTION AND DRAIN AMYLASE OF GREATER THAN 150,000 U/L, NECESSITATING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH PANCREATIC STENT INSERTION. HER RECOVERY WAS SUBSEQUENTLY COMPLICATED BY RECURRENT SYMPTOMATIC INTRA-ABDOMINAL BLEEDING REQUIRING MULTIPLE ADMISSIONS TO THE SURGICAL INTENSIVE CARE UNIT, 3 FURTHER RELOOK LAPAROTOMIES FOR WASHOUT AND HEMOSTASIS, AND 1 GELFOAM EMBOLIZATION OF PSEUDOANEURYSM, FOR WHICH MULTIPLE MASSIVE TRANSFUSIONS WERE NEEDED FOR BLOOD LOSS AND COAGULOPATHY, AND CARDIOPULMONARY RESUSCITATION WAS REQUIRED ONCE INTRAOPERATIVELY FOR PULSELESS ELECTRICAL ACTIVITY. IN VIEW OF MULTIORGAN FAILURE, PERSISTENT POOR NEUROLOGICAL RECOVERY, AND INABILITY TO WEAN OFF LIFE SUPPORT, DECISION WAS EVENTUALLY MADE IN DISCUSSION WITH HER FAMILY FOR NON ESCALATION OF CARE. SHE EVENTUALLY DIED 97 DAYS AFTER HER INITIAL OPERATION. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: BASED ON AVAILABLE INFORMATION, A POSSIBLE CONTRIBUTORY ROLE OF THE SUBJECT PRODUCT CANNOT BE EXCLUDED FOR THE REPORTED EVENTS DUE TO TEMPORAL RELATIONSHIP. HOWEVER, THE REPORTED EVENTS MAY POSSIBLY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN THIS PATIENT. THERE IS LIMITED INFORMATION PROVIDED IN THIS REPORT. ADDITIONAL INFORMATION IS NEEDED TO BETTER ASSESS THE CASE, INCLUDING COMPLETE MEDICAL HISTORY, DIAGNOSTICS, COUNTERACTIVE TREATMENT MEASURES AND CONCOMITANT MEDICATIONS. THIS CASE WILL BE REASSESSED ONCE ADDITIONAL INFORMATION IS AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
EVENT VERBATIM [PREFERRED TERM] MULTIORGAN FAILURE [MULTIPLE ORGAN DYSFUNCTION SYNDROME], PERSISTENT POOR NEUROLOGICAL RECOVERY [NERVOUS SYSTEM DISORDER], , NARRATIVE: THIS CASE HAS BEEN CONSIDERED INVALID AS F/UP NULLIFICATION - COUNTRY OF PRIMARY SOURCE CHANGED AT FOLLOW-UP. THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "UNUSUAL CASE OF DELAYED RUPTURE OF PANCREATIC NEUROENDOCRINE TUMOR AFTER ENDOSCOPIC ULTRASOUND AND BIOPSY", PANCREAS, 2022; VOL:51 (5), PGS:E79-E80. A 79-YEAR-OLD FEMALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HAEMOSTASIS. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "PANCREATIC NEUROENDOCRINE TUMOR (PNET)" (UNSPECIFIED IF ONGOING); "CRAMPY EPIGASTRIC PAIN" (UNSPECIFIED IF ONGOING); "HYPOTENSIVE" (UNSPECIFIED IF ONGOING); "DROWSINESS" (UNSPECIFIED IF ONGOING); "ABDOMINAL DISTENSION" (UNSPECIFIED IF ONGOING); "METABOLIC ACIDOSIS" (UNSPECIFIED IF ONGOING); "PERCUTANEOUS ANGIOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "EXPLORATORY LAPAROTOMY" (UNSPECIFIED IF ONGOING); "PANCREATOSPLENECTOMY" (UNSPECIFIED IF ONGOING); "BILATERAL PULMONARY EMBOLISM" (UNSPECIFIED IF ONGOING); "PANCREATIC-NECK, THICK-WALLED CYST" (UNSPECIFIED IF ONGOING), NOTES: WITH MILD PANCREATIC DUCT DILATATION, EUS AND FNA WERE PERFORMED; "PNET WAS NOTED TO HAVE RUPTURED" (UNSPECIFIED IF ONGOING). THE PATIENT TOOK CONCOMITANT MEDICATIONS. THE FOLLOWING INFORMATION WAS REPORTED: MULTIPLE ORGAN DYSFUNCTION SYNDROME (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "MULTIORGAN FAILURE"; NERVOUS SYSTEM DISORDER (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "PERSISTENT POOR NEUROLOGICAL RECOVERY". THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "MULTIORGAN FAILURE", "PERSISTENT POOR NEUROLOGICAL RECOVERY". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: WE REPORT A RARE CASE OF PNET WITH POSSIBLE DELAYED IATROGENIC RUPTURE 2MONTHS AFTER EUS AND FNA. OUR PATIENT WITH A PANCREATIC NECK PNET INCIDENTALLY DISCOVERED AS A CYST WITH SOLID COMPONENT DURING HER ROUTINE ABDOMINAL ULTRASOUND FOR HEPATITIS B FOLLOW-UP. A CT OF HER PANCREAS WAS PERFORMED, WHICH FURTHER CHARACTERIZED THE LESION AS A 3.4-CM PANCREATIC-NECK, THICK-WALLED CYST WITH MILD PANCREATIC DUCT DILATATION. AN EUS AND FNA WERE PERFORMED USING A 19-GAUGE NEEDLE, REQUIRING MULTIPLE PASSES. HISTOLOGY YIELDED WELL-DIFFERENTIATED NEUROENDOCRINE CELLS. SHE WAS PLANNED FOR SURGERY PENDING CARDIAC WORKUP AS SHE ALSO RECENTLY UNDERWENT AN AORTIC VALVE REPLACEMENT HALF A YEAR PRIOR, WITH RECOVERY COMPLICATED BY COMPLETE HEART BLOCK NEEDING INSERTION OF PERMANENT PACEMAKER, AS WELL AS BILATERAL PULMONARY EMBOLISM REQUIRING LIFELONG ANTICOAGULATION. SHE PRESENTED 2 MONTHS AFTER FNA WITH A WEEK HISTORY OF CRAMPY EPIGASTRIC PAIN WITH NEITHER OTHER GASTROINTESTINAL SYMPTOMS NOR FEVER. A CT PERFORMED REVEALED THAT HER PNET HAS GROWN TO 4.9 CM, WITH RUPTURE AND HEMORRHAGE TO THE PERIPANCREATIC AND PERIGASTRIC REGIONS. UPON ADMISSION, SHE QUICKLY BECAME HYPOTENSIVE, AND AN URGENT CT MESENTERIC ANGIOGRAM REVEALED ACTIVE CONTRAST EXTRAVASATION INTO THE PANCREATIC MASS VIA A SMALL BRANCH OF THE PANCREATICODUODENAL ARTERY. INITIAL TREATMENT WITH PERCUTANEOUS ANGIOEMBOLIZATION WAS ATTEMPTED, BUT AS OUR PATIENT REMAINED PERSISTENTLY HYPOTENSIVE WITH WORSENING DROWSINESS, ABDOMINAL DISTENSION, AND METABOLIC ACIDOSIS, THE DECISION WAS HENCE MADE FOR EXPLORATORY LAPAROTOMY. INTRAOPERATIVELY, MASSIVE BLEEDING OF UP TO 15 L WAS ENCOUNTERED REQUIRING MASSIVE TRANSFUSION. THE PNET WAS NOTED TO HAVE RUPTURED AND INVOLVED THE MAIN BRANCHES OF THE SUPERIOR MESENTERIC VEIN. CLOT EVACUATION, ADHESIOLYSIS, AND SUBTOTAL PANCREATOSPLENECTOMY WERE PERFORMED WITH TEMPORARY CLOSURE. THE PATIENT WAS STABILIZED IN THE INTENSIVE CARE UNIT OVERNIGHT BEFORE A RELOOK LAPAROTOMY, HEMOSTASIS, AND SECONDARY CLOSURE WERE PERFORMED THE FOLLOWING DAY. HISTOLOGY REVEALED A WELL-DIFFERENTIATED PNET WITH LYMPHOVASCULAR INVASION AND NEGATIVE RESECTION MARGINS. ALTHOUGH OUR PATIENT WAS ABLE TO BE WEANED OFF INOTROPES INITIALLY POSTOPERATIVELY, SHE SUBSEQUENTLY DEVELOPED POSTOPERATIVE PANCREATIC FISTULA, WITH CT DEMONSTRATING A GALLBLADDER FOSSA COLLECTION AND DRAIN AMYLASE OF GREATER THAN 150,000 U/L, NECESSITATING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH PANCREATIC STENT INSERTION. HER RECOVERY WAS SUBSEQUENTLY COMPLICATED BY RECURRENT SYMPTOMATIC INTRA-ABDOMINAL BLEEDING REQUIRING MULTIPLE ADMISSIONS TO THE SURGICAL INTENSIVE CARE UNIT, 3 FURTHER RELOOK LAPAROTOMIES FOR WASHOUT AND HEMOSTASIS, AND 1 GELFOAM EMBOLIZATION OF PSEUDOANEURYSM, FOR WHICH MULTIPLE MASSIVE TRANSFUSIONS WERE NEEDED FOR BLOOD LOSS AND COAGULOPATHY, AND CARDIOPULMONARY RESUSCITATION WAS REQUIRED ONCE INTRAOPERATIVELY FOR PULSELESS ELECTRICAL ACTIVITY. IN VIEW OF MULTIORGAN FAILURE, PERSISTENT POOR NEUROLOGICAL RECOVERY, AND INABILITY TO WEAN OFF LIFE SUPPORT, DECISION WAS EVENTUALLY MADE IN DISCUSSION WITH HER FAMILY FOR NON ESCALATION OF CARE. SHE EVENTUALLY DIED 97 DAYS AFTER HER INITIAL OPERATION. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO AMEND PREVIOUS INFORMATION: THIS CASE IS BEING DELETED FROM THE DATABASE FOR THE FOLLOWING REASON: F/UP NULLIFICATION - COUNTRY OF PRIMARY SOURCE CHANGED AT FOLLOW-UP., COMMENT: BASED ON AVAILABLE INFORMATION, A POSSIBLE CONTRIBUTORY ROLE OF THE SUBJECT PRODUCT CANNOT BE EXCLUDED FOR THE REPORTED EVENTS DUE TO TEMPORAL RELATIONSHIP. HOWEVER, THE REPORTED EVENTS MAY POSSIBLY REPRESENT INTERCURRENT MEDICAL CONDITIONS IN THIS PATIENT. THERE IS LIMITED INFORMATION PROVIDED IN THIS REPORT. ADDITIONAL INFORMATION IS NEEDED TO BETTER ASSESS THE CASE, INCLUDING COMPLETE MEDICAL HISTORY, DIAGNOSTICS, COUNTERACTIVE TREATMENT MEASURES AND CONCOMITANT MEDICATIONS. THIS CASE WILL BE REASSESSED ONCE ADDITIONAL INFORMATION IS AVAILABLE. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1156551 | ABSORBABLE GELATIN | SPONGE, STERILE; CLASS III | LMF | PFIZER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Death| O |