MAUDE Adverse Event Report: ETHICON INC. MERSILENE TAPE UNKNOWN PRODUCT; INSTRUMENT, SURGICAL, DISPOSABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Citation: ann thorac surg.2000; 70: 97-9.(b)(4).

Event Description

It was reported via journal article: title: "ten-year experience with mersilene-reinforced sternal wound closure," authors: matthew m.Puc, md; charles h.Antinori, md; dioscoro t.Villanueva, md; michael tarnoff, md; john a.Heim, md.Citation: ann thorac surg.2000; 70: 97-9.The authors reviewed the experience with mersilene-reinforced sternal wound closure to evaluate its overall morbidity and its impact on patient management.The study included 1039 patients who underwent median sternotomy with mersilene-reinforced sternal wound closure over the past 10 years.Of which, 866 patients underwent coronary artery bypass grafting, 170 patients underwent valve only repair, and 3 patients underwent other cardiac procedures.During the surgical procedure, a mersilene tape 5mm (ethicon) was used for closure of the median sternotomy.A steel wire was first placed in standard fashion at the top of the manubrium.This was followed by four 5-mm mersilene tapes on a blunt needle, which were passed around the lateral edge of the sternum through the intercostal spaces: one around the manubrium and three around the body of the sternum.At the lower end of the sternum, a second stainless steel wire was placed below the mersilene tapes.The sternum was first pulled together by twisting down the steel wires and then secured with the mersilene tapes.The knots from the mersilene tape were placed at the edge of the sternum away from the middle of the incision.An assistant was needed to hold the first knot in the mersilene tape while the surgeon completes tying the tape to secure a tight sternal closure.Reported post-operative complications included sternal dehiscence (n-6) which required inpatient treatment, sternal wound infection (n-19) which required local operative debridement with preservation of a significant portion of the sternum, and deep sternal wound infection (n-6) which required extensive debridement with major reconstructive repair and long-term intravenous antibiotic therapy.Mersilene tape has a practical utility in sternotomy closure.It has been shown to have similar complication rates to the standard stainless steel wire closure with an added benefit.It tends to maintain the integrity of the sternum without the potential for a piecemeal destruction of the sternum when dehiscence does occur.This appears to be its major benefit over steel wire that deserves attention and consideration.

• Brand Name: MERSILENE TAPE UNKNOWN PRODUCT
• Type of Device: INSTRUMENT, SURGICAL, DISPOSABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8056597
• MDR Text Key: 126919102
• Report Number: 2210968-2018-77081
• Device Sequence Number: 1
• Product Code: KDC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention