ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

Report

Report Number: 2210968-2024-10473
Event Type: Injury
Date Received: October 2, 2024
Date of Event: August 30, 2021
Manufacturer: ETHICON INC.
Product Code: GAT
PMA / PMN Number: K946173
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PO
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

(B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. AN ATTEMPT HAS BEEN MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. CITATION: REV BRAS GINECOL OBSTET 2021;43(7):570¿577. DOI HTTPS://DOI.ORG/10.1055/S-0041-1735153.

Description of Event or Problem · 0

TITLE: CONSERVATIVE MANAGEMENT OF SPONDYLODISCITIS AFTER LAPAROSCOPIC SACRAL COLPOPEXY: A CASE REPORT AND REVIEW OF LITERATURE. THIS STUDY REPORTS A CASE OF A 65-YEAR-OLD MULTIPAROUS WOMAN WITH A PREVIOUS HISTORY OF TYPE II DIABETES MELLITUS, HYPERTENSION, DYSLIPIDEMIA, BILATERALP GONARTHROSIS AND GOUTY ARTHROPATHY WAS REFERRED TO THE AUTHOR'S HOSPITAL DUE TO COMPLAINTS OF POP. A PHYSICAL EXAMINATION REVEALED A STAGE 3 PROLAPSE WITH UTERINE LEADING EDGE ACCORDING TO THE POP QUANTIFICATION SYSTEM (POP-Q),9 AND SHE UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND SACRAL COLPOPEXY. A NON-ABSORBABLE PROLENE SOFT MESH (GYNECARE GYNEMESH (ETHICON, LLC, SAN LORENZO, PORTO RICO)) WAS ATTACHED TO THE ANTERIOR AND POSTERIOR VAGINAL WALLS (ONE SUTURE ANTERIORLY AND TWO SUTURES POSTERIORLY) AND TO THE SACRAL PROMONTORY (ONE SUTURE) USING A STERILE NONABSORBABLE BRAIDED POLYESTER SURGICAL SUTURE (ETHIBOND EXCEL, ETHICON, INC., SOMERVILLE, NJ, USA). AT THE LEVEL OF THE LEVATOR ANI MUSCLE, A STERILE ABSORBABLE POLYDIOXANONE MONOFILAMENT SUTURE (PDS II 2/0 - ETHICON, INC., SOMERVILLE, NJ, USA) WAS USED. THE MESH WAS PERITONEALIZED USING AN ABSORBABLE SYNTHETIC POLYGLACTIN BRAIDED SUTURE (VICRYL 1/0 - ETHICON, INC., SOMERVILLE, NJ, USA). INTRAVENOUS CEFAZOLIN (2 G) WAS ADMINISTERED AS PERIOPERATIVE ANTIMICROBIAL PROPHYLAXIS. THE SURGERY AND THE IMMEDIATE POSTOPERATIVE PERIOD WERE UNEVENTFUL. REPORTED COMPLICATIONS INCLUDE LUMBOSACRAL MINOR PAIN ONE MONTH AFTER THE SURGERY. HER URINE ANALYSIS WAS POSITIVE FOR LEUCOCYTES AND PROTEINS, AND ORAL ANTIBIOTIC AMBULATORY TREATMENT (AMOXICILLIN/CLAVULANIC ACID, ACCORDING TO NATIONAL GUIDELINES FOR UNCOMPLICATED URINARY TRACT INFECTION) WAS PRESCRIBED. THREE MONTHS POSTOPERATIVELY, THE PATIENT WAS READMITTED WITH PROGRESSIVE AND INTENSE LUMBOSACRAL PAIN RADIATING TO BOTH LOWER LIMBS AND SEVERE GAIT LIMITATION. HER BLOOD TESTS REVEALED AN ELEVATED C-REACTIVE PROTEIN (CRP 9.51MG/DL) WITH A NORMAL WHITE CELL COUNT. THE REMAINING BLOOD TESTS WERE UNREMARKABLE. A COMPUTED TOMOGRAPHY (CT) EXAM SHOWED AN ANTERIOR INTERRUPTION OF THE BONE CORTICAL IN L5 AND S1 WITH INFLAMMATORY REACTION INVOLVING THE INTERVERTEBRAL DISC. A MAGNETIC RESONANCE IMAGING (MRI) EXAM REVEALED AN ACCENTUATED EDEMA OF THE SOMATIC L5 AND S1 SPONGE WITH EROSIVE ANOMALIES IN THE VERTEBRAL PLATES OF THESE VERTEBRAE, SUGGESTIVE OF SPONDYLODISCITIS WITH ASSOCIATED PHLEGMON WITH ANTERIOR EXTENSION TO THE SACRUM AND TO THE POSTERIOR PERIDURAL REGION (¿FIG. 1). AFTER MULTIDISCIPLINARY DISCUSSION (INTERNAL MEDICINE, GYNECOLOGY AND ORTHOPEDICS), THE MOST LIKELY DIAGNOSIS OF SPONDYLODISCITIS AFTER SACRAL COLPOPEXY WAS ASSUMED AND A CONSERVATIVE MANAGEMENT WAS IMPLEMENTED (BROAD-SPECTRUM INTRAVENOUS ANTIBIOTIC THERAPY AND PHYSIOTHERAPY). THE PATIENT FULFILLED 6 DAYS OF INTRAVENOUS EMPIRIC THERAPY WITH VANCOMYCIN AND CEFTRIAXONE (ACCORDING TO INTERNATIONAL GUIDELINES REGARDING VERTEBRAL OSTEOMYELITIS) AND THEN, AFTER DISCUSSION WITH THE INFECTIOUS DISEASES CONSULTANT, CONTINUED WITH 19 DAYS OF INTRAVENOUS AMOXICILLIN AND CLAVULANIC ACID (TO COVER ANAEROBIC AGENTS, INCLUDING BACTERIOIDES SPP.), WITH PROGRESSIVE CLINICAL (PAIN, GAIT) AND ANALYTICAL (CRP 1.11MG/DL AT DISCHARGE) IMPROVEMENT. THE MRI FINDINGS ON THE 18TH DAY OF HOSPITALIZATION REMAINED STABLE AND WITHOUT NEUROLOGIC INVOLVEMENT. THE PATIENT WAS DISCHARGED ON THE 25TH DAY OF HOSPITALIZATION, WITHOUT REQUIRING ANALGESIC MEDICATION AND MEDICATED WITH AMOXICILLIN AND CLAVULANIC ACID PER OS (UNTIL COMPLETING A TOTAL OF 6 WEEKS OF ANTIBIOTIC THERAPY WITH AMOXICILLIN AND CLAVULANIC ACID). IN CONCLUSION, BACK PAIN ASSOCIATED WITH ELEVATED CRP AFTER THIS PROCEDURE SHOULD LEAD US TO FURTHER INVESTIGATION TO ACHIEVE A PROMPT DIAGNOSIS AND INITIATE ADEQUATE TREATMENT. A CONSERVATIVE APPROACH WITHOUT MESH REMOVAL MAY BE POSSIBLE WITH VIGILANT ATTENTION. HOWEVER, HEMOCULTURES AND IMAGE-GUIDED BIOPSY/ASPIRATION OF THE INFECTION SITE SHOULD NOT BE NEGLECTED, SINCE THE MICROORGANISMS CAUSING THIS COMPLICATION MAY BE DIFFERENT FROM THE TYPICAL STAPHYLOCOCCUS SPP. AND STREPTOCOCCUS SPP. RESPONSIBLE FOR 50% OF OTHER TYPES OF SPONDYLODISCITIS. IF EMPIRICAL TREATMENT IS PRESCRIBED, IT SHOULD ALSO COVER ANAEROBE, TO COVER FOR BACTEROIDES SPP., WHICH IS ONE OF THE MOST COMMON MICROORGANISMS DETECTED IN THIS COMPLICATION. THE PATIENT SHOULD BE ADMITTED FOR ATTENTIVE SURVEILLANCE AND INTRAVENOUS ANTIBIOTIC THERAPY AND ANALGESIA. THE AUTHORS RECOMMEND CONSERVATIVE TREATMENT IN STABLE PATIENTS WITHOUT VAGINAL MESH EXPOSURE, VAGINAL LESION, NEURAL COMPRESSION, NEUROLOGIC DEFICIT, PROGRESSIVE DEFORMATION, OR INSTABILITY. IF THERE IS A FAVORABLE RECOVERY OF CLINICAL SYMPTOMS AND ANALYTICAL PARAMETERS, CONSERVATIVE TREATMENT SHOULD BE MAINTAINED WITH PROLONGED ANTIBIOTIC THERAPY FOR AT LEAST 6 WEEKS. ON THE OTHER HAND, NEUROLOGICAL AGGRAVATION OR CONSERVATIVE TREATMENT FAILURE SHOULD REDIRECT THE APPROACH FOR A SURGICAL TREATMENT. IT IS ALSO OF PARAMOUNT IMPORTANCE THAT A MULTIDISCIPLINARY TEAM IS IMPLICATED IN THE FOLLOW-UP OF THESE PATIENTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1948809	ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN	SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE	GAT	ETHICON INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR	Female	Required Intervention