SEPRAMESH IP

Report

Report Number: 1213643-2022-00763
Event Type: Injury
Date Received: December 1, 2022
Date of Event: September 29, 2015
Report Date: February 7, 2023
Manufacturer: DAVOL INC., SUB. C.R. BARD, INC. -1213643
Product Code: FTL
PMA / PMN Number: K063739
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE. AS REPORTED, PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS. THE REPORTED COMPLICATIONS ARE KNOWN INHERENT RISKS OF SURGERY/USE OF THE DEVICE. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE IDENTIFIES SEROMA, HEMATOMA, PAIN, INFECTION, AND RECURRENCE OF THE HERNIA AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE PROSTHESIS. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE PROSTHESIS." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE.THIS MDR REPRESENTS THE SEPRAMESH IP. ADDITIONAL MDRS WERE SUBMITTED TO REPRESENT VENTRIO ST MESH, VENTRALIGHT ST MESH AND VENTRALIGHT ST W/ECHO PS.NOTE, THE DATE OF EVENT ((B)(6) 2015) IS PROVIDED AS A BEST ESTIMATE BASED ON THE INFORMATION PROVIDED.

Additional Manufacturer Narrative · 0

BASED ON THE INFORMATION PROVIDED, NO CONCLUSIONS CAN BE MADE. THE INFORMATION OBTAINED IS LIMITED TO THE ARTICLE. AS REPORTED, PATIENTS EXPERIENCED POSTOPERATIVE COMPLICATIONS. THE REPORTED COMPLICATIONS ARE KNOWN INHERENT RISKS OF SURGERY/USE OF THE DEVICE. THE ADVERSE REACTION SECTION OF THE INSTRUCTIONS-FOR-USE (IFU), SUPPLIED WITH THE DEVICE IDENTIFIES SEROMA, HEMATOMA, PAIN, INFECTION, AND RECURRENCE OF THE HERNIA AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE IFU STATES, "IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE PROSTHESIS. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE PROSTHESIS." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. ADDENDIUM: THE ADVERSE EVENT WAS NOT RELATED TO THE THE DEVICE OR THE WAY THE DEVICE WAS USED. THE ADDITIONAL INFORMATION PROVIDED BY THE SURGEON CONFIRMED THAT THE HERNIA RECURRENCES LISTED IN THE JOURNAL ARTICLE WERE OUTSIDE OF THE INITIAL HERNIA REPAIR AREA, AND WERE NOT CAUSED OR CONTRIBUTED BY ANY ISSUE WITH THE INITIAL IMPLANTED HERNIA MESH. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON COMBINED WITH THE DETAILS IN THE JOURNAL ARTICLE, THERE IS NO ALLEGATION OR INDICATION THAT THE SEROMA, HEMATOMA, AND INFECTION OUTCOMES INCLUDED IN THE ARTICLE ARE MESH RELATED. THIS MDR REPRESENTS THE JOURNAL ARTICLE¿S ¿SECOND CASE¿ HERNIA RECURRENCE, SEPRAMESH IP DEVICE. ACTUAL PRODUCT REMAINS UNKNOWN, SEPRAMESH IP REPRESENTS A POTENTIAL PRODUCT BASED ON THE INFORMATION PROVIDED. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : NOT RETURNED.

Description of Event or Problem · 0

PER JOURNAL ARTICLE IN HERNIA (2022) TITLED, ¿SEVEN YEARS OF PREOPERATIVE BTA ABDOMINAL WALL PREPARATION AND THE MACQUARIE SYSTEM FOR SURGICAL MANAGEMENT OF COMPLEX VENTRAL HERNIA.¿ FEATURED WAS A SINGLE-CENTER PROSPECTIVE COHORT STUDY BETWEEN NOVEMBER 2012 AND DECEMBER 2019, 88 CONSECUTIVE PATIENTS UNDERWENT COMPLEX VENTRAL HERNIA (CVH) REPAIR USING PRE-OPERATIVE BOTULINUM TOXIN A (BTA) INJECTION AND THE MACQUARIE SYSTEM OF MANAGEMENT WITH BARD/DAVOL SEPRAMESH, VENTRIO ST, VENTRALIGHT ST AND VENTRALIGHT ST W/ECHO PS. CLINICAL EXAMINATION AND FUNCTIONAL NON-CONTRAST ABDOMINAL CT SCANS, ULTRASOUNDS WERE USED TO ASSESS COMPLICATIONS AND RECURRENCES ENCOUNTERED. SURGICAL COMPLICATIONS OCCURRED IN 22 (25.0%) PATIENTS. RECURRENCE 2 (2.3%), HEMATOMA (REQUIRED INTERVENTION) 2 (2.3%), SEROMA 7 (8.0% REQUIRED ASPIRATIONS), INFERIOR EPIGASTRIC ARTERY BLEED 1 (1.1% REQUIRED EMBOLIZATION), ONE (1.1%) PATIENT HAD A SUPERFICIAL SURGICAL SITE INFECTION MANAGED WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE, SUTURE IRRITATION 1(1.1%). IT WAS ALSO REPORTED THAT A PATIENT DEVELOPED CENTRAL ABDOMINAL PAIN 9 MONTHS AFTER THE OPERATION. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. THIS FILE IS FILED TO DOCUMENT THE SEPRAMESH.

Description of Event or Problem · 0

PER JOURNAL ARTICLE IN HERNIA (2022) TITLED, ¿SEVEN YEARS OF PREOPERATIVE BTA ABDOMINAL WALL PREPARATION AND THE MACQUARIE SYSTEM FOR SURGICAL MANAGEMENT OF COMPLEX VENTRAL HERNIA.¿ FEATURED WAS A SINGLE-CENTER PROSPECTIVE COHORT STUDY BETWEEN NOVEMBER 2012 AND DECEMBER 2019, 88 CONSECUTIVE PATIENTS UNDERWENT COMPLEX VENTRAL HERNIA (CVH) REPAIR USING PRE-OPERATIVE BOTULINUM TOXIN A (BTA) INJECTION AND THE MACQUARIE SYSTEM OF MANAGEMENT WITH BARD/DAVOL SEPRAMESH, VENTRIO ST, VENTRALIGHT ST AND VENTRALIGHT ST W/ECHO PS. CLINICAL EXAMINATION AND FUNCTIONAL NON-CONTRAST ABDOMINAL CT SCANS, ULTRASOUNDS WERE USED TO ASSESS COMPLICATIONS AND RECURRENCES ENCOUNTERED. SURGICAL COMPLICATIONS OCCURRED IN 22 (25.0%) PATIENTS. RECURRENCE 2 (2.3%), HEMATOMA (REQUIRED INTERVENTION) 2 (2.3%), SEROMA 7 (8.0% REQUIRED ASPIRATIONS), INFERIOR EPIGASTRIC ARTERY BLEED 1 (1.1% REQUIRED EMBOLIZATION), ONE (1.1%) PATIENT HAD A SUPERFICIAL SURGICAL SITE INFECTION MANAGED WITH ANTIBIOTICS AND PERCUTANEOUS DRAINAGE, SUTURE IRRITATION 1(1.1%). IT WAS ALSO REPORTED THAT A PATIENT DEVELOPED CENTRAL ABDOMINAL PAIN 9 MONTHS AFTER THE OPERATION. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS. THIS FILE IS FILED TO DOCUMENT THE SEPRAMESH. ADDENDIUM: PER JOURNAL ARTICLE IN SPRINGER-VERLAG JUNE 2021 TITLED, ¿SEVEN YEARS OF PREOPERATIVE BTA ABDOMINAL WALL PREPARATION AND THE MACQUARIE SYSTEM FOR SURGICAL MANAGEMENT OF COMPLEX VENTRAL HERNIA.¿: THE STUDY INCLUDED 88 PATIENTS TREATED FOR A COMPLEX VENTRAL HERNIA (CVH) DURING A 7-YEAR PERIOD. ALL HERNIA DEFECTS WERE SUCCESSFULLY CLOSED USING EITHER LAPAROSCOPIC OR LAPAROSCOPIC-ASSISTED OPEN TECHNIQUES FACILITATED BY PRE-OPERATIVE BOTULINUM TOXIN A (BTA) INJECTION. ALL LAPAROSCOPIC REPAIRS USED A BARD SEPRAMESH IP OR A BARD VARIANT OF THE SEPRAMESH (BARD HERNIA MESH WITH A ST COATING COMPONENT). THE ARTICLE IDENTIFIES: (A) THERE WERE NO BTA COMPLICATIONS; (B) POST-OPERATIVE WOUND-RELATED COMPLICATIONS (WITH NO ALLEGATION/INDICATION OF BEING DEVICE RELATED) INCLUDED 7 PATIENTS WITH SEROMAS AND 2 PATIENTS WITH HEMATOMAS REQUIRING INTERVENTION; (C) 2 PATIENTS WHO DEVELOPED HERNIA RECURRENCES. ARTICLE HERNIA RECURRENCE SUMMARY: THE RECURRENCE RELATED TO THE SECOND CASE NOTED THE PATIENT HAD DEVELOPED CENTRAL ABDOMINAL PAIN 9 MONTHS AFTER THE OPERATION BUT DID NOT DEVELOP ANY CORRESPONDING CLINICAL BULGE UNTIL 12 MONTHS AFTER THE OPERATION. CT OBTAINED AT THIS POINT SHOWED A 4 CM ¿SWISS-CHEESE¿ SUPRA-UMBILICAL HERNIA LOCATED ABOVE THE MESH OF REPAIR. THE HERNIA ¿FIELD¿ INCLUDED MULTIPLE FASCIAL DEFECTS ON THE BACKGROUND OF A WIDENED LINEA ALBA. THIS RECURRENCE WAS MANAGED WITH A LAPAROSCOPIC RECONSTRUCTION OF THE ABDOMINAL MIDLINE FROM THE LEVEL OF XIPHISTERNUM TO THE PREVIOUS REPAIR USING POLYPROPYLENE SEPRAFILM COMPOSITE MESH IN THE IPOM POSITION. ADDENDUM PER ADDITIONAL INFORMATION RECEIVED FROM THE SURGEON REGARDING THE SECOND CASE: ¿THIS PATIENT¿S RECURRENCE WAS OUTSIDE THE MESH/RECONSTRUCTION AREA & REPRESENTED A FAILURE BY THE SURGICAL TEAM (US) TO EXTEND THE HERNIA REPAIR AND MESH WELL BEYOND THE PRIMARY DEFECT. CLINICALLY THE PATIENT WAS WELL WITH NO HERNIA SYMPTOMS AT LAST REVIEW.¿

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2769982	SEPRAMESH IP	SURGICAL MESH	FTL	DAVOL INC., SUB. C.R. BARD, INC. -1213643	NA	NI

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Required Intervention