MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS SPECTRA CONCEALABLE PENILE PROSTHESIS; PROSTHESIS, PENILE

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

Patient Problems Erosion (1750); Fistula (1862); Unspecified Infection (1930); Necrosis (1971)

Event Type  Injury  

Event Description

It was reported via journal article that following, the spectra penile prosthesis implant the patient experienced "extensive distal penile tissue necrosis and anterior urethral loss." the device was removed and multiple debridements were performed.Eight weeks post-implant the patient received further treatment for "continued necrosis and infection of the glans and distal penile shaft." "physical examination revealed erosive ulceration with fibrinous exudate on the dorsal surface of the penis, an open would with fibrinous exudate on the ventral aspect, erosion of the corpus spongiosum with urethral fistula at the mid-distal shaft, eschar at the glans, and induration of the proximal ventral shaft." "the patient underwent operative exploration, debridement, and washout.During initial exploration of the would penile morphology was difficult to discern secondary to infectious destruction of the tissue planes.The tip of the glans penis was completely necrotic within a 2 cm diameter surrounding the meatus, and no clear corpora cavernosa nor corpus spongiosum could be identified.The foley catheter was found to be within the true urethral lumen proximally and distally, but a 2 cm mid-shaft ventral urethral defect was clearly evident.Intraoperative plastic surgery consultation was obtained, and [hydrosurgery system] debridement of he surrounding tissue was accomplished.After debridement of all devitalized tissue, fistulization extending from the ventral aspect of the filleted shaft to a 1 cm opening on the dorsal aspect was discovered.A suprapubic tube was placed for urinary diversion, and a silastic foley catheter was left in place to maintain the urethral lumen while the patient received intravenous antibiotics and local wound care with (antimicrobial barrier) silver dressings as an inpatient." "five days later, the patient was brought back to the operating room for attempted primary urethroplasty and reconstruction.At this time, the urethra was noted to be intact only for its distal 0.3cm and at the base of the penile shaft, with an intervening 50% circumferential ventral 2.5cm defect at the mid-shaft.To reconstruct the ventral defect, a square of [adm] graft was cut to appropriate size and positioned over the defect, sutured along the lateral aspect of the defect to the remaining urethral tissue with 5-0 [monofilament synthetic absorbable] suture in an interrupted fashion, further trimmed to size and sutured over a silastic foley catheter medially and superiorly, thus covering the entire urethral defect.We constructed a neomeatus from the distal urethral and spatulated it circumferentially so that the catheter exited at the tip of the reconstructed glans.The fistulous tract was closed primarily with [synthetic absorbable] suture, and the plastic surgery service primarily closed the filleted shaft soft tissue flaps over the urethral defect to produce a slightly foreshortened but otherwise cosmetically acceptable and penis of sufficient functional length for voiding.The silastic catheter was left in place post-operatively to stent open the urethra and provide a mold around which the [acellular dermal matrix] could revascularize and reepithelialize." "over the ensuing 6 months of follow up the patient's postoperative course has been uneventful.One month after surgery, the silastic foley catheter was removed and the suprapubic tube clamped.Two weeks later, the suprapubic tube was removed, and [the patient] has been voiding normally with a cosmetically acceptable and functional penis.At 17 months follow up, retrograde urethrography continues to show a normal patent urethra with no evidence of stricture or fistula.".

Manufacturer Narrative

Carpenter, c.P., daniali, l.N., shah, n.P., garnick, m., and jordan, m.L.2012.Distal urethral reconstruction with alloderm: a case report and review of the literature.The canadian journal of urology19(2): 6207-6210.

• Brand Name: AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 3827477
• MDR Text Key: 4390724
• Report Number: 2183959-2014-00172
• Device Sequence Number: 1
• Product Code: FAE
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention
• Patient Age: 68 YR