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

Device Problem Malposition of Device (2616)

Patient Problem 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.No specific patient information regarding events has been provided.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Does the surgeon believe that ethicon product (pds, vicryl, prolene) caused and/or contributed to the adverse events described in the article? was there any alleged deficiency relating to ethicon products used? has this event been previously reported to ethicon? can specific patient demographics be provided? reference attached journal article.

Event Description

It was reported in a journal article entitled: orbitomalar suspension during high smas facelift authors: steven r.Cohen, md, facs., don o.Kikkawa, md., bobby s.Korn, md, phd, facs citation: aesthetic surgery journal.2010; 30(1): 22 29.Doi: 10.1177/1090820x10362729 in many patients, facial aging increases demarcation of the nasolabial, malar, and nasojugal folds.In part, this may be related to involution of the orbitomalar ligament, as well as deflation of facial soft tissues and bones.The objective of this study is to present orbitomalar suspension (oms) as an extension of the high smas facelift that further improves medial superior repositioning of the cheek and blending of the lower eyelid and cheek junction during facelift surgery while also ensuring virtually no change in lower eyelid position.A total of 60 patients underwent oms as the final step of the facelift procedure.A preauricular superficial musculo-aponeurotic system (smas) flap was cut and transposed along the lower mandibular border to the mastoid area, and the remaining smas was elevated vertically and posteriorly and sutured with pds 4-0 running suture.Once the orbitomalar ligament was released, a vicryl 4-0 or prolene 4-0 suture was placed into the suborbicularis oculi fat (soof) and retrieved from the upper eyelid incision along the supraperiosteal level.This suture was tied to the lateral orbital rim periosteum, and the excess skin and muscle of the lower eyelid were trimmed.A second vicryl 5-0 suture was then placed in the orbicularis oculi and retrieved in a more superficial plane from the upper eyelid.This suture was also tied to the periosteum of the lateral orbital rim.Reported complications included palpable, slightly visible vicryl knots on 1 or both lateral upper eyelids (n-3), in 1 patient, the right side was re-opened with limited incision and the knot was removed, unilateral left ectropion (n-1) which required revision surgery, and transient lower eyelid malposition (n-2) which required gentle massage and lateral eyelid support with steri-strips.It was concluded that in properly selected patients, oms in concert with high smas facelift may be a more definitive means of addressing the ptotic cheek and lower eyelid.The oms complements the deeper plane by adding a medial and superior vector of elevation to the cheek; blending of the lower eyelidcheek junction is accomplished with little risk of lower eyelid malposition.Additional information has been requested.

• Brand Name: PDS II POLYDIOXANONE SUTURE
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC; route 22 west; somerville NJ 00876
• Manufacturer Contact: darlene kyle ; route 22 west; somerville, NJ 00876 ; 9082182792
• MDR Report Key: 7356358
• MDR Text Key: 102998824
• Report Number: 2210968-2018-71551
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 03/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention