PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2024-05740
- Event Type
- Injury
- Date Received
- June 3, 2024
- Date of Event
- November 13, 2021
- Report Date
- June 7, 2024
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- PMA / PMN Number
- K061037
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. H6 (ANNEX E): ENDOTENSION CORRECTION: H6 (ANNEX E) INVESTIGATION-EVALUATION ON 29FEB2024 COOK BECAME AWARE OF A JOURNAL ARTICLE, ¿LONG-TERM RESULTS AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR USING THE COOK ZENITH ENDOGRAFT. JOURNAL OF VASCULAR SURGERY¿ WRITTEN BY MERTENS, J., HOUTHOOFD, S., DAENENS, K., FOURNEAU, I., MALEUX, G., LERUT, P., & NEVELSTEEN, A. ACCORDING TO THE LITERATURE THE STUDY ASSESSED THE LONG-TERM OUTCOME OF PATIENTS WITH ABDOMINAL AORTIC AND AORTOILIAC ANEURYSMS TREATED WITH THE COOK ZENITH ENDOVASCULAR GRAFT. PER THE LITERATURE BETWEEN SEPTEMBER 1998 AND OCTOBER 2003, 143 PATIENTS (134 MEN AND NINE WOMEN) UNDERWENT ELECTIVE ENDOVASCULAR ANEURYSM REPAIR (EVAR) USING THE COOK ZENITH ENDOGRAFT. DATA FROM THESE PATIENTS WERE REVIEWED FROM A PROSPECTIVE DATABASE IN OCTOBER 2008. PRIMARY OUTCOME MEASURES WERE OVERALL SURVIVAL, INTERVENTION-FREE SURVIVAL, AND FREEDOM FROM ANEURYSM RUPTURE. SECONDARY OUTCOME MEASURES WERE EARLY AND LATE POSTOPERATIVE COMPLICATIONS, INCLUDING ENDOLEAKS. THE ARTICLE LISTS PREOPERATIVE PATIENT RISK STRATIFICATION USING THE SOCIETY FOR VASCULAR SURGERY (SVS)/INTERNATIONAL SOCIETY FOR CARDIOVASCULAR SURGERY (ISCVS) RISK SCORING SYSTEM. THIS CAN BE FOUND IN TABLE III (ONLINE ONLY). LISTED VARIABLES INCLUDE DIABETES, SMOKING, HYPERTENSION, HYPERLIPIDEMIA, CARDIAC STATUS, CAROTID STATUS, RENAL STATUS AND PULMONARY STATUE. HOWEVER, THE INFORMATION IS DE-IDENTIFIED AND CANNOT BE LINKED TO SPECIFIC PATIENTS. THIS REPORT WILL CAPTURE THE PATIENT WHO HAD A LATE POSTOPERATIVE COMPLICATION OF ENDOTENSION ON THE MAIN BODY GRAFT AND REQUIRED OPEN CONVERSION. THIS INFORMATION CAN BE FOUND IN TABLE VII OF THE JOURNAL ARTICLE THAT LISTS POSTOPERATIVE COMPLICATIONS AND REINTERVENTIONS. ALTHOUGH THE LITERATURE PROVIDES SOME INFORMATION REGARDING PATIENT ANATOMY THE INFORMATION IS DE-IDENTIFIED AND IS UNABLE TO BE LINKED TO THE SPECIFIC PATIENTS. THE LITERATURE INDICATES THE DEVICE USED IN THE STUDY WAS A TRI-FAB DEVICE BY COOK MEDICAL. THE TRI-FAB DESIGN CORRESPONDS WITH THE TFB DEVICE (ZENITH AAA ENDOVASCULAR GRAFT). THEREFORE, DOCUMENTATION WAS PULLED FOR THE TFB DEVICE IN THIS INVESTIGATION. REVIEWS OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), QUALITY CONTROL, AND SPECIFICATIONS WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. THERE WAS ONE STILL IMAGE PROVIDED IN THE LITERATURE. HOWEVER, THE IMAGE WAS DE-IDENTIFIED AND COULD NOT BE LINKED TO A SPECIFIC PATIENT. THE STILL IMAGE IS A PLAIN ABDOMINAL RADIOGRAPH AND SHOWS A DISCONNECTION OF THE BARE METAL TOP STENT FORM THE ZENITH ENDOGRAFT BODY. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION IN THE ARTICLE. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE DEVICE STATES THE FOLLOWING IN CONSIDERATION OF THE REPORTED FAILURE MODE: ¿2 INDICATIONS FOR USE THE ZENITH AAA ENDOVASCULAR GRAFT WITH THE H&L-B ONE-SHOT INTRODUCTION SYSTEM AND ANCILLARY COMPONENTS IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC OR AORTOILIAC ANEURYSMS HAVING MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: ¿ ADEQUATE ILIAC/FEMORAL ACCESS COMPATIBLE WITH THE REQUIRED INTRODUCTION SYSTEM, ¿ NON-ANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSM: ¿ WITH A LENGTH OF AT LEAST 15 MM ¿ WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 28 MM AND NO LESS THAN 18 MM, ¿ WITH AN ANGLE LESS THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND ¿ WITH AN ANGLE LESS THAN 45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA. ¿ ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL). 4 WARNINGS AND PRECAUTIONS 4.1 GENERAL ¿ ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING AN ENLARGING ANEURYSM, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP ) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. ¿ PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ¿ THE ZENITH AAA ENDOVASCULAR GRAFT IS DESIGNED TO TREAT AORTIC NECK DIAMETERS NO SMALLER THAN 18 MM AND NO LARGER THAN 28 MM. THE ZENITH AAA ENDOVASCULAR GRAFT IS DESIGNED TO TREAT PROXIMAL AORTIC NECKS (DISTAL TO THE LOWEST RENAL ARTERY) OF AT LEAST 15 MM IN LENGTH. ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. ¿ KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVER PROXIMAL NECK ANGULATION (>60 DEGREES FOR INFRARENAL NECK TO AXIS OF AAA OR >45 DEGREES FOR SUPRARENAL NECK RELATIVE TO THE IMMEDIATE INFRARENAL NECK); SHORT PROXIMAL AORTIC NECK (15 MM); AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15 MM OF PROXIMAL AORTIC NECK LENGTH); AND CIRCUMFERENTIAL THROMBUS AND/OR CALCIFICATION AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IN THE PRESENCE OF ANATOMICAL LIMITATIONS, A LONGER NECK MAY BE REQUIRED TO OBTAIN ADEQUATE SEALING AND FIXATION. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE ATTACHMENT AND SEALING AT THE FIXATION SITES. NECKS EXHIBITING THESE KEY ANATOMICAL ELEMENTS MAYBE MORE CONDUCIVE TO GRAFT MIGRATION OR ENDOLEAK. 4.4 DEVICE SELECTION ¿ STRICT ADHERENCE TO THE ZENITH AAA ENDOVASCULAR GRAFT IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE. APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING OR COMPRESSION. 4.5 IMPLANT PROCEDURE ¿ APPROPRIATE PROCEDURAL IMAGING IS REQUIRED TO SUCCESSFULLY POSITION THE ZENITH AAA ENDOVASCULAR GRAFT AND ASSURE ACCURATE APPOSITION TO THE AORTIC WALL. ¿ TO AVOID ANY TWIST IN THE ENDOVASCULAR GRAFT, DURING ANY ROTATION OF THE DELIVERY SYSTEM, BE CAREFUL TO ROTATE ALL COMPONENTS OF THE SYSTEM TOGETHER (FROM OUTER SHEATH TO INNER SHEATH) ¿ DO NOT CONTINUE ADVANCING ANY PORTION OF THE DELIVERY SYSTEM IF RESISTANCE IS FELT DURING ADVANCEMENT OF THE WIRE GUIDE OR DELIVERY SYSTEM. STOP AND ASSESS THE CAUSE OF RESISTANCE; VESSEL, CATHETER OR GRAFT DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS OR IN CALCIFIED OR TORTUOUS VESSELS. ¿ INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS. ¿ INADEQUATE FIXATION OF THE ZENITH AAA ENDOVASCULAR GRAFT MAY RESULT IN INCREASED RISK OF MIGRATION OF THE STENT GRAFT. INCORRECT DEPLOYMENT OR MIGRATION OF THE ENDOPROSTHESIS MAY REQUIRE SURGICAL INTERVENTION. 5.2 POTENTIAL ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ¿ ANEURYSM ENLARGEMENT ¿ ANEURYSM RUPTURE AND DEATH ¿ ENDOLEAK ¿ ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; BARB SEPARATION AND CORROSION ¿ SURGICAL CONVERSION TO OPEN REPAIR 7.1 INDIVIDUALIZATION OF TREATMENT ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: ¿ PATIENT¿S AGE AND LIFE EXPECTANCY ¿ CO-MORBIDITIES (E.G., CARDIAC, PULMONARY OR RENAL INSUFFICIENCY PRIOR TO SURGERY, MORBID OBESITY) ¿ PATIENT¿S SUITABILITY FOR OPEN SURGICAL REPAIR ¿ PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR ¿ THE RISK OF ANEURYSM RUPTURE COMPARED TO THE RISK OF TREATMENT WITH THE ZENITH AAA ENDOVASCULAR GRAFT ¿ ABILITY TO TOLERATE GENERAL, REGIONAL OR LOCAL ANESTHESIA ¿ ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIFICATION AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES OF THE DELIVERY PROFILE OF A 14 TO 20 FRENCH VASCULAR INTRODUCER SHEATH ¿ NON-ANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSM: ¿ WITH A LENGTH OF AT LEAST 15 MM, ¿ WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 28 MM AND NO LESS THAN 18 MM, ¿ WITH AN ANGLE LESS THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND ¿ WITH AN ANGLE LESS THAN 45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA ¿ ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5 TO 20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) ¿ FREEDOM FROM SIGNIFICANT FEMORAL/ILIAC ARTERY OCCLUSIVE DISEASE THAT WOULD IMPEDE FLOW THROUGH THE ENDOVASCULAR GRAFT THE FINAL TREATMENT DECISION IS AT THE DISCRETION OF THE PHYSICIAN AND PATIENT. 8 PATIENT COUNSELING INFORMATION PHYSICIANS SHOULD REFER THE PATIENT TO THE PATIENT GUIDE REGARDING RISKS OCCURRING DURING OR AFTER IMPLANTATION OF THE DEVICE. PROCEDURE RELATED RISKS INCLUDE CARDIAC, PULMONARY, NEUROLOGIC, BOWEL AND BLEEDING COMPLICATIONS. DEVICE-RELATED RISKS INCLUDE OCCLUSION, ENDOLEAK, ANEURYSM ENLARGEMENT, FRACTURE, POTENTIAL FOR REINTERVENTION AND OPEN SURGICAL CONVERSION, RUPTURE AND DEATH (SEE SECTION 5.1, OBSERVED ADVERSE EVENTS AND SECTION 5.2, POTENTIAL ADVERSE EVENTS). THE PHYSICIAN SHOULD COMPLETE THE PATIENT I.D. CARD AND GIVE IT TO THE PATIENT SO THAT HE/ SHE CAN CARRY IT WITH HIM/HER AT ALL TIMES. THE PATIENT SHOULD REFER TO THE CARD ANYTIME HE/SHE VISITS ADDITIONAL HEALTH PRACTITIONERS, PARTICULARLY FOR ANY ADDITIONAL DIAGNOSTIC PROCEDURES (E.G., MRI). PRE-IMPLANT DETERMINANTS VERIFY FROM PRE-IMPLANT PLANNING THAT THE CORRECT DEVICE HAS BEEN SELECTED. DETERMINANTS INCLUDE: 1. FEMORAL ARTERY SELECTION FOR INTRODUCTION OF THE MAIN BODY SYSTEM (I.E., DEFINE RESPECTIVE CONTRALATERAL AND IPSILATERAL ILIAC ARTERIES). 2. ANGULATION OF AORTIC NECK, ANEURYSM AND ILIAC ARTERIES. 3. QUALITY OF THE AORTIC NECK. 4. DIAMETERS OF INFRARENAL AORTIC NECK AND DISTAL ILIAC ARTERIES. 5. DISTANCE FROM RENAL ARTERIES TO THE AORTIC BIFURCATION. 6. LENGTH FROM THE AORTIC BIFURCATION TO THE INTERNAL ILIAC ARTERIES/ATTACHMENT SITE(S). 7. ANEURYSM(S) EXTENDING INTO THE ILIAC ARTERIES MAY REQUIRE SPECIAL CONSIDERATION IN SELECTING A SUITABLE GRAFT/ARTERY INTERFACE SITE. 8. CONSIDER THE DEGREE OF VASCULAR CALCIFICATION.¿ BASED ON THE AVAILABLE INFORMATION, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE ASSOCIATED RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED (VICRYL SUTURE, PDSII PLUS SUTURE, BLAKE DRAIN) CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: SURGICAL SITE INFECTION: INCISIONAL SSI, ORGAN/SPACE SSI, BOTH INCISIONAL/ORGAN SSI, GASTROINTESTINAL BLEEDING, INTRA-ABDOMINAL BLEEDING, SUBCUTANEOUS BLEEDING, ILEUS, CATHETER INFECTION, CLAVIEN¿DINDO GRADE = III , DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (VICRYL SUTURE, PDSII PLUS SUTURE, BLAKE DRAIN) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WHICH SPECIFIC ETHICON PRODUCTS (VICRYL SUTURE, PDSII PLUS SUTURE, BLAKE DRAIN) HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATIONS : ANNALS OF GASTROENTEROLOGICAL SURGERY. VOL.6: PAGES 375¿385. DOI: 10.1002/AGS3.12530 THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. TRADE NAME - IRGACARE®, ACTIVE INGREDIENT(S) ¿ TRICLOSAN, DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL, STRENGTH ¿ = 2360 G/M. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
TITLE :USEFULNESS OF BACTERIAL CULTURE OF DRAINAGE FLUID FOR PREDICTING SURGICAL SITE INFECTION AFTER CROHN¿S DISEASE SURGERY. THE AIM OF THIS STUDY WAS TO EVALUATE THE USEFULNESS OF BACTERIAL CULTURE OF POSTOPERATIVE DRAINAGE FLUID AFTER CD SURGERY. A TOTAL OF 110 CONSECUTIVE PATIENTS WHO UNDERWENT CROHN'S DISEASE (CD) SURGERY BETWEEN JANUARY 2010 AND MARCH 2020 AT OSAKA UNIVERSITY HOSPITAL WERE INCLUDED IN THIS STUDY. THERE WERE 84 MEN AND 26 WOMEN. BEFORE MARCH 2012, WE PERFORMED CLOSED PASSIVE DRAINAGE USING SURGEON'S CHOICE OF A SILASCON DUPLE DRAIN (KANEKA MEDICAL PRODUCTS, JAPAN) OR CLOSED ACTIVE DRAINAGE USING A BLAKE SILICONE DRAIN (ETHICON, CINCINNATI, OH).THE PERITONEUM WAS CLOSED BY A RUNNING SUTURE WITH 3-0 VICRYL (ETHICON). THE MUSCULAR FASCIA WAS CLOSED BY A KNOTTED SUTURE WITH 1-PDS PLUS (ETHICON). THE WOUND WAS WASHED WITH 200 ML OF SALINE BEFORE CLOSURE OF THE SKIN BY A BURIED SUTURE WITH 4-0 PDS PLUS (ETHICON). THE REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION: INCISIONAL SSI (N=12),ORGAN/SPACE SSI (N=2) & BOTH INCISIONAL/ORGAN SSI (N=4) , GASTROINTESTINAL BLEEDING (N=5), INTRA-ABDOMINAL BLEEDING (N=1), SUBCUTANEOUS BLEEDING (N=1), ILEUS (N=5), CATHETER INFECTION (N=4) AND CLAVIEN¿ DINDO GRADE = III (N=7). IN CONCLUSION, THIS STUDY SUGGESTS THE USEFULNESS OF POSTOPERATIVE DRAINAGE FLUID BACTERIAL CULTURE FOR EARLY DIAGNOSIS OF SSI AFTER CD SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 998523 | PDS LL PLUS ANTIBACTERIAL SUTURE UNKNOWN PRODUCT | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |