STRATTICE
Report
- Report Number
- 1000306051-2014-00042
- Event Type
- Injury
- Date Received
- June 19, 2014
- Date of Event
- May 21, 2014
- Report Date
- June 19, 2014
- Manufacturer
- LIFECELL CORPORATION
- Product Code
- FTM
- PMA / PMN Number
- K070560
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
INTERNAL INVESTIGATION CONFIRMED THAT COMPLAINT RELATED LOT SP100033 DID MEET QC RELEASE CRITERIA. SKIN NECROSIS, WOUND DEHISCENCE AND WOUND INFECTIONS ARE ANTICIPATED POST OPERATIVE COMPLICATIONS IN BREAST RECONSTRUCTION PROCEDURES WITH ISSUES RELATED TO SURGICAL TECHNIQUE AND PATIENT COMORBIDITIES ALSO BEING CONTRIBUTING FACTORS. PSEUDOMONA AERUGINOSA IS AN OPPORTUNISTIC PATHOGEN THAT FREQUENTLY CAUSES HOSPITAL-ACQUIRED SURGICAL SITE INFECTIONS IN DEBILITATED, IMMUNOCOMPROMISED PATIENTS AND HAS BEEN ASSOCIATED WITH SURGICAL SITE INFECTIONS IN BREAST CANCER SURGERIES. CANDIDA ALBICANS IS AN OPPORTUNISTIC HUMAN FUNGAL PATHOGEN THAT CAUSES INFECTIONS IN IMMUNOCOMPROMISED PATIENTS. INFLAMMATORY CHANGES SUCH AS CELL INFILTRATION AND INCREASED VASCULARIZATION IN THE BIOLOGICAL MESHES ARE THE PART OF NORMAL HEALING PROCESS. THE EVENT IS UNLIKELY RELATED TO THE STUDY DEVICE THAT REMAINS IMPLANTED.
INTERNAL INVESTIGATION CONFIRMED THAT COMPLAINT RELATED LOT SP100033 DID MEET QC RELEASE CRITERIA. SKIN NECROSIS, WOUND DEHISCENCE AND WOUND INFECTIONS ARE ANTICIPATED POST OPERATIVE COMPLICATIONS IN BREAST RECONSTRUCTION PROCEDURES WITH ISSUES RELATED TO SURGICAL TECHNIQUE AND PATIENT COMORBIDITIES ALSO BEING CONTRIBUTING FACTORS. PSEUDOMONA AERUGINOSA IS AN OPPORTUNISTIC PATHOGEN THAT FREQUENTLY CAUSES HOSPITAL-ACQUIRED SURGICAL SITE INFECTIONS IN DEBILITATED, IMMUNOCOMPROMISED PATIENTS AND HAS BEEN ASSOCIATED WITH SURGICAL SITE INFECTIONS IN BREAST CANCER SURGERIES. INFLAMMATORY CHANGES SUCH AS CELL INFILTRATION AND INCREASED VASCULARIZATION IN THE BIOLOGICAL MESHES ARE THE PART OF NORMAL HEALING PROCESS. THE EVENT IS UNLIKELY RELATED TO THE STUDY DEVICE.
INTERNAL INVESTIGATION INCLUDED, AS FOLLOWS: - REVIEW OF THE INFORMATION REPORTED. - REVIEW OF THE DEVICE HISTORY RECORD FOR LOT SP100033, WITH NO REMARKABLE FINDINGS; THERE WERE NO PROCESSING DEVIATIONS RELATED TO THE SAFETY OF THE PRODUCT; LOT UNDERWENT TERMINAL STERILIZATION ((B)(4) 2013); Q2-2013 DOSE AUDIT FOR STERILIZATION PROCESS WAS ACCEPTABLE TO SUPPORT PRODUCTION IN Q3-2013. - (B)(4) - QUERY OF LIFECELL COMPLAINT SYSTEM DID NOT REVEAL ANY OTHER SIMILAR COMPLAINTS REPORTED AGAIN THIS LOT CONCLUSION: BASED ON INFORMATION REPORTED AND INTERNAL INVESTIGATION INTO COMPLAINT RELATED LOT SP100033, WITH NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THE GRAFTS DISTRIBUTED, THE EVENT, SKIN NECROSIS- DEVICE EXPOSURE, IS UNLIKELY RELATED TO THE DEVICE. LIFECELL REPORTS THIS EVENT TO FDA DUE TO INVESTIGATOR'S ASSESSMENT, "THE EVENT RELATIONSHIP IS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE". INTERNAL INVESTIGATION CONFIRMED THAT COMPLAINT RELATED LOT DID MEET QC RELEASE CRITERIA. SKIN NECROSIS AND WOUND INFECTIONS ARE ANTICIPATED POST OPERATIVE COMPLICATIONS IN BREAST RECONSTRUCTION PROCEDURES WITH ISSUES RELATED TO SURGICAL TECHNIQUE AND PATIENT COMORBIDITIES ALSO BEING CONTRIBUTING FACTORS. PSEUDOMONA AERUGINOSA IS AN OPPORTUNISTIC PATHOGEN THAT FREQUENTLY CAUSES HOSPITAL-ACQUIRED SURGICAL SITE INFECTIONS IN DEBILITATED, IMMUNOCOMPROMISED PATIENTS AND HAS BEEN ASSOCIATED WITH SURGICAL SITE INFECTIONS IN BREAST CANCER SURGERIES.
INFORMATION BELOW INCLUDES PREVIOUSLY REPORTED ( MAY 08,2014 TO MAY 25,2014, REF. EMDR1000306051-2014-00042, INITIAL REPORT), INFORMATION RECEIVED ON JUNE 19,2014 (JUNE 19,2014 TO JUNE 21, 2014, REF. EMDR1000306051-2014-00042, F/UP#1 FILED ON 07/16/2014) AND UPDATED INFORMATION RECEIVED ON JULY 17,2014 (SEE JUNE 19, 2014 IN DESCRIPTION BELOW) THAT IS SUBJECT OF THIS F/UP#2-FINAL REPORT. ON (B)(6) 2014, THE SUBJECT (B)(6) FEMALE ENROLLED IN LIFECELL SPONSORED CLINICAL STUDY - ESSBR (REF. PROTOCOL LFC2012.06.01), UNDERWENT LEFT MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION WITH IMPLANT AND LIFECELL DEVICE. 400 GRAMS OF BREAST TISSUE WAS REMOVED. DURING THE POST OPERATIVE PERIOD, THE PATIENT HAD KLEBSIELLA INFECTION REPORTED WHICH WAS TREATED WITH ANTIBIOTICS. ON (B)(6) 2014 (POD13), THE PATIENT WAS HOSPITALIZED FOR SKIN NECROSIS AND DEVICE EXPOSURE ON THE LEFT BREAST. THE EVENT WAS RESOLVED ON THE SAME DAY AFTER SKIN SUTURING AND CHANGE OF IMPLANT. THE BREAST IMPLANT WAS REPLACED WITH TISSUE EXPANDER. LIFECELL DEVICE WAS LEFT IN PLACE. ACCORDING TO THE SURGEON, THE BACTERIAL ANALYSIS SHOWED PRESENCE OF BACTERIA THAT IS USUAL IN NECROTIC TISSUE. BACTERIAL CULTURE RESULTS SHOWED PRESENCE OF PSEUDOMONAS AERUGINOSA. THE PATIENT WAS REPORTED AS FINE. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED. ON (B)(6) 2014, THE PATIENT PRESENTED WITH WOUND DEHISCENCE WITH EXPANDER EXPOSURE AND WAS HOSPITALIZED. SKIN EXCISION WAS PERFORMED, EXPANDER WAS REMOVED, AND A SAMPLE WAS TAKEN FROM LIFECELL DEVICE FOR HISTOLOGICAL EVALUATION. HISTOLOGY SHOWED INFLAMMATORY CHANGES. BACTERIAL CULTURE RESULTS SHOWED PRESENCE OF PSEUDOMONAS AERUGINOSA AND CANDIDA ALBICANS. ON (B)(6) 2014, SAE WAS RESOLVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.
INFORMATION BELOW INCLUDES PREVIOUSLY REPORTED (MAY 08, 2014 TO MAY 25, 2014, REF. EMDR 1000306051-2014-00042, INITIAL REPORT) AND UPDATED INFORMATION RECEIVED ON JUNE 19,2014 (JUNE 19, 2014 TO JUNE 21, 2014) THAT IS SUBJECT OF THIS COMBINED FOLLOW-UP AND FINAL REPORT, AS FOLLOWS: ON (B)(6) 2014, THE SUBJECT (B)(6) FEMALE ENROLLED IN LIFECELL SPONSORED CLINICAL STUDY - ESSBR (REF. PROTOCOL LFC2012.06.01), UNDERWENT LEFT MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION WITH IMPLANT AND LIFECELL DEVICE. 400 GRAMS OF BREAST TISSUE WAS REMOVED. DURING THE POST OPERATIVE PERIOD, THE PATIENT HAD KLEBSIELLA INFECTION REPORTED WHICH WAS TREATED WITH ANTIBIOTICS. ON (B)(6) 2014 (POD13), THE PATIENT WAS HOSPITALIZED FOR SKIN NECROSIS AND DEVICE EXPOSURE ON THE LEFT BREAST. THE EVENT WAS RESOLVED ON THE SAME DAY AFTER SKIN SUTURING AND CHANGE OF IMPLANT. THE BREAST IMPLANT WAS REPLACED WITH TISSUE EXPANDER. LIFECELL DEVICE WAS LEFT IN PLACE. ACCORDING TO THE SURGEON, THE BACTERIAL ANALYSIS SHOWED PRESENCE OF BACTERIA THAT IS USUAL IN NECROTIC TISSUE. BACTERIAL CULTURE RESULTS SHOWED PRESENCE OF PSEUDOMONAS AERUGINOSA. THE PATIENT WAS REPORTED AS FINE. ON (B)(6) 2014, THE PATIENT WAS DISCHARGED ON (B)(6) 2014, THE PATIENT PRESENTED WITH WOUND DEHISCENCE WITH EXPANDER EXPOSURE AND WAS HOSPITALIZED. SKIN EXCISION WAS PERFORMED, EXPANDER WAS REMOVED, AND A SAMPLE WAS TAKEN FROM LIFECELL DEVICE FOR HISTOLOGICAL EVALUATION. HISTOLOGY SHOWED INFLAMMATORY CHANGES. ON (B)(6) 2014, SAE WAS RESOLVED, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.
IT WAS REPORTED TO LIFECELL, AS FOLLOWS: - ON (B)(6) 2014, THE SUBJECT, (B)(6) YEAR-OLD FEMALE ENROLLED IN LIFECELL SPONSORED CLINICAL STUDY - (B)(6), UNDERWENT LEFT MASTECTOMY AND IMMEDIATE BREAST RECONSTRUCTION WITH IMPLANT AND LIFECELL DEVICE. 400 GRAMS OF BREAST TISSUE WAS REMOVED. DURING THE POST OPERATIVE PERIOD, THE PATIENT HAD KLEBSIELLA INFECTION REPORTED WHICH WAS TREATED WITH ANTIBIOTICS. - ON (B)(6) 2014 (POD13), THE PATIENT WAS HOSPITALIZED FOR SKIN NECROSIS AND DEVICE EXPOSURE ON THE LEFT BREAST. THE EVENT WAS RESOLVED ON THE SAME DAY AFTER SKIN SUTURING AND CHANGE OF IMPLANT. THE BREAST IMPLANT WAS REPLACED WITH TISSUE EXPANDER. LIFECELL DEVICE WAS LEFT IN PLACE. ACCORDING TO THE SURGEON, THE BACTERIAL ANALYSIS SHOWED PRESENCE OF BACTERIA THAT IS USUAL IN NECROTIC TISSUE. BACTERIAL CULTURE RESULTS SHOWED PRESENCE OF PSEUDOMONAS AERUGINOSA. THE PATIENT REPORTED AS FINE. - ON (B)(6) 2014, THE PATIENT WAS DISCHARGED. THE INVESTIGATOR ASSESSED THE EVENT RELATIONSHIP AS POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 361050 | STRATTICE | SURGICAL MESH | FTM | LIFECELL CORPORATION | 1016001EU | SP100033-052 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |