MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Fistula (1862); Hernia (2240); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? citation: hernia (2012) 16:451¿460; doi 10.1007/s10029-012-0919-0; published online: 23 may 2012.[(b)(4)].

Event Description

It was reported via journal article: "title: early repair of open abdomen with a tailored two-component mesh and conditioning vacuum packing: a safe alternative to the planned giant ventral hernia" authors: u.A.Dietz, c.Wichelmann, c.Wunder, j.Kauczok, l.Spor, a.Strauss, r.Wildenauer, c.Jurowich and c.T.Germer citation: hernia (2012) 16:451¿460; doi 10.1007/s10029-012-0919-0; published online: 23 may 2012.The aim of this paper was to present the surgical technique and results of this novel staged procedure, a new four-stage procedure involving the application of a two-component mesh and vacuum conditioning for abdominal wall closure of even large defects that has the advantages of early patient mobilization and a low complication rate.There were 19 patients (7 males, 12 females with average age of 60.76 (14.50)) where the four-stage abdominal wall closure with two-component mesh was performed and 21 patients (11 males, 10 females with average age of 62.76 (11.97)) where the linea alba suture technique was applied.To achieve closure in these patients, the authors applied the following four-stage procedure: stage 1: abdominal damage control and conditioning of the abdominal wall; stage 2: attachment of a tailored two component mesh of polyglycolic acid (pga) and large pore polypropylene (pp) in intraperitoneal position (ipom) plus placement of a vacuum bandage; stage 3: vacuum therapy for 3¿4 weeks to allow granulation of the mesh and optimization of dermatotraction; stage 4: final skin suture.During the procedure, the two-component mesh was positioned with the pga mesh in the ipom position on the intestinal convolution, extended under the facial defect, and attached transfascially; if possible, the suture holes were made lateral to the rectus abdominis.To avoid tear-out, the epifascial knots were tied over a pledget (ethisorb, ethicon, usa).For vacuum conditioning, a polyurethane sponge (kci-medical, usa) was tucked laterally beneath the subcutaneous tissue.The 2 to 3 suction drains running parallel to each other were placed on the granulated two component mesh at 5-cm intervals.To prevent dislocation of the drains, these could be attached with a 5-0 usp rapid-absorbable suture to the pp component (e.G., safil quick_ or vicryl rapid).The four-stage procedure was concluded with subcutaneous suture and donati skin suture with prolene 2-0 usp.In the group of patients with primary abdominal wall closure, the linea alba was sutured with a pds 1 usp loop suture or reconstruction was done by implantation of a pp mesh in retromuscular sublay position with the placement of subcutaneous and/or retromuscular suction drainage for 5¿6 days.In the linea alba suture: wound revision (n=4), stoma complication (n=1), bowel fistulas (n=1), incissional hernia (n=3) were reported.In the 2-component mesh included: wound infection (conservative) (n=1), methylene-resistant staphylococcus aureus (mrsa) colonization (n=1), computerized tomogram (ct)-guided abscess drainage (n=2), and chronic pain (n=1) were reported.In conclusion, the four-stage procedure presented here is a viable option for achieving abdominal wall closure in patients treated with open abdomen, enabling us to avoid the development of planned giant ventral hernias.It has few complications and has the special advantage of allowing mobilization of the patients before final skin closure.Long-term course in a large number of patients must still confirm this result.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• 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: 7681410
• MDR Text Key: 113783673
• Report Number: 2210968-2018-74281
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2018
• 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