PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT
Report
- Report Number
- 2210968-2025-01385
- Event Type
- Injury
- Date Received
- February 5, 2025
- Date of Event
- October 24, 2023
- Report Date
- February 5, 2025
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
PRODUCT COMPLAINT # (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. ATTEMPTS ARE BEING 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? 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATIONS: E. J. CLIN.MED. 2023, 12, 6713. HTTPS://DOI.ORG/10.3390/JCM12216713.
TITLE: AORTIC VALVE REPLACEMENT IN ADULT PATIENTS WITH DECELLULARIZED HOMOGRAFTS: A SINGLE-CENTER EXPERIENCE. THE AIM OF THIS STUDY WAS TO REPORT OUR SINGLE CENTER EXPERIENCE WITH DECELLULARIZED AORTIC HOMOGRAFTS SINCE 2016. ALL ADULT PATIENTS (N=73) UNDERGOING AORTIC VALVE REPLACEMENT WITH DECELLULARIZED AORTIC HOMOGRAFTS (DAH) BETWEEN 2016 AND 2023 AT OUR CENTER WERE INCLUDED INTO THIS RETROSPECTIVE SINGLE CENTER COHORT STUDY. THE PROXIMAL ANASTOMOSIS IS PERFORMED WITH THREE 4-0 POLYPROPYLENE SUTURES (PROLENE ). CORONARY OSTIA ARE ANASTOMOSED IN STANDARD FASHION USING A 6-0 POLYPROPYLENE SUTURE IN CONTINUOUS TECHNIQUE. THE DISTAL ANASTOMOSIS BETWEEN HOMOGRAFT AND ASCENDING AORTA IS PERFORMED USING CONTINUOUS 5-0 POLYPROPYLENE SUTURE. THE REPORTED COMPLICATIONS INCLUDED COMPLETE ATRIOVENTRICULAR BLOCK (N=1), TORSADE DE POINTES VENTRICULAR TACHYCARDIA AND ROCS (N=1), AND PERICARDIAL EFFUSION (N=1). IN CONCLUSION, EARLY AND MID-TERM RESULTS SHOWED LOW MORTALITY AND 100% FREEDOM FROM REOPERATION, THROMBOEMBOLIC EVENTS, AND BLEEDING AT OUR CENTER. FUTURE STUDIES ARE NEEDED TO EVALUATE THE LONG-TERM PERFORMANCE OF THE DAH, WHICH COULD BE A SAFE AND EFFICIENT ALTERNATIVE TO THE ROUTINE TECHNIQUES OF AORTIC VALVE REPLACEMENT IN YOUNG ADULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1245474 | PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |