MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 0 S/A CT LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number W9236T

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

Patient Problem Bone Fracture(s) (1870)

Event Date 09/23/2019

Event Type  Injury  

Event Description

Title: reabsorbable pins can reinforce an early sternal stability after median sternotomy in young children with congenital heart disease this retrospective study aims to compare the sternal stability and healing susceptibility of the two sternal closure types by using physical examination and threedimensional computed tomography in open cardiac surgery patients whose body weights were less than 10 kg.Between october 2016 and may 2018, a traditional open heart surgery on 169 chd-diagnosed children with body weights under 10 kg was performed by a single surgeon using the same technique at the second (b)(6).After correction of the cardiac malformations, sternal closure on 85 patients (42 males and 43 females) age (10.46 ± 3.22 months) was performed by using bioresorbable poly-l-lactide sternal reinforced device (sternum pin, (b)(4)) in combination with the ethicon polydioxanone pdstmii (w9236t, ethicon, inc, (b)(4)) running sutures (group a), while ethicon polydioxanone pdstmii cord sutures alone were used on another cohort of 84 patients (group b) with 39 males and 45 females age (9.63 ± 3.29 months).Reported complications included: group a: mild sternal caudal-cranial displacement (n=4); incidence of caudal-cranial displacement in the patients with different diagnosis; postoperatively:ventricular septal defect (n=6) , atrial septal defect (n=1), ventricular; septal defect+ atrial septal defect (n=4) , atrial septal defect+ pulmonary stenosis (n=1) ,tetralogy of fallot (n=2).Group b: pectus carinatum (protrusion of the sternum, also called ¿pigeon chest¿) was observed patients in group b, at postoperative 4 weeks (n=10), sternal caudal-cranial displacement (n=5) ,sternal displacement with the skin raised in the anterior-posterior direction (n=10) ,sternal dehiscence (n=7) , incidence of dehiscence in the patients with different diagnosis postoperatively: ventricular septal defect (n=5), atrial septal defect (n=1), ventricular septal defect+ atrial septal defect (n=3) , atrial septal defect+ pulmonary stenosis (n=1), tetralogy of fallot (n=2).Incidence of caudal-cranial displacement in the patients with different diagnosis postoperatively:(n=7) ventricular septal defect, (n=1)atrial septal defect , (n=4) ventricular septal defect+ atrial septal defect, (n=1) atrial septal defect+ pulmonary stenosis, (n=2) tetralogy of fallot.Incidence of anterior-posterior displacements in the patients with different diagnosis postoperatively: (n=8) ventricular septal defect, (n=1)atrial septal defect , (n=5) ventricular septal defect+ atrial septal defect, (n=2) atrial septal defect+ pulmonary stenosis, (n=3) tetralogy of fallot.

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.The single complaint was reported with multiple events.There are no additional details, demographics regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Does the author/surgeon believe that ethicon products (pds ii suture- w9236t) involved caused and/or contributed to post-op complications in group a (mild sternal caudal-cranial displacement and caudal-cranial displacement in the patients with different diagnosis post-op) described in the article? please specify.Does the author/surgeon believe that ethicon products (pds cord unknown) involved caused and/or contributed to post-op complications in group b (pectus carinatum, sternal caudal-cranial displacement, sternal displacement with the skin raised in the anterior-posterior direction, dehiscence in the patients with different diagnosis post-op, caudal-cranial displacement in the patients with different diagnosis post-op and anterior-posterior displacements in the patients with different diagnosis post-op ) described in the article? please specify.Does the author/surgeon believe there was any deficiency with the ethicon products (pds ii suture- w9236t and pds cord unknown) used in this study? if yes, please describe.If yes, please provide patient demographics for patients that experienced the post-operative complications in both groups a and b? were any post-op medical/surgical interventions required for post-op complications in both groups? if yes, please specify.Were all these cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Citation: pediatric cardiology (2019) 40:1728¿1734.Https://doi.Org/10.1007/s00246-019-02212-1.Events were submitted via 2210968-2021-10556.

• Brand Name: PDSII VIO 60IN 0 S/A CT LP
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12716583
• MDR Text Key: 284895261
• Report Number: 2210968-2021-10557
• 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,health professional,l
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W9236T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Patient Sequence Number: 1