MAUDE Adverse Event Report: COLOPLAST A/S GENESIS MALLEABLE; PENILE PROSTHESIS

Model Number 5192501400

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

Patient Problems Unspecified Infection (1930); Pain (1994); Numbness (2415)

Event Type  Injury  

Event Description

Title: comparison of patient-reported outcomes after penile prosthesis placement in men with and without peyronie's disease.We evaluated outcomes in patients undergoing penile prothesis (pp) implantation for erectile dysfunction (ed) and concurrent peyronie¿s disease (pd).A clinician-developed survey to assess satisfaction was sent to 354 patients who underwent pp placement from 2012¿2018 by a single-surgeon.Results were compared based on the presence or absence of concurrent pd.79 patients completed the survey (response rate 22%), including 38 patients (48%) with concurrent ed and pd (ed/pd).Mean follow-up was 31 months (standard deviation 19).87% felt their condition was ¿very much¿ or ¿much¿ improved.There was no significant difference in patient-reported overall satisfaction with their pp or satisfaction with current penile length/girth based on the presence or absence of pd.87% of patients with pd were satisfied with their degree of penile straightening after pp plus or minus concurrent straightening maneuvers such as modeling, plication, or incision/grafting.Sub-group analyses were performed to evaluate outcomes in those with concurrent pd/ed who required plaque incision/grafting at the time of pp placement for more severe deformity (n = 19).47% of these patients were dissatisfied with their current penile length, compared with only 16% of those patients with pd/ed who did not require grafting (p = 0.05).In conclusion, the presence of pd alone may not impact pp satisfaction, but patients with more severe baseline deformity who require incision/grafting may be less satisfied with outcomes including penile length.Method after obtaining institutional review board approval (18121813-irb01), we identified all patients =18 years of age who underwent pp by a single surgeon (lal) between may 2012 and august 2018 (electronic medical record era).Patients with a history of prior pp surgery or those undergoing revision surgery were excluded, as were those who were deceased or did not have updated contact information.A retrospective chart review was carried out to populate a patient database.Pertinent variables of interest included preoperative medical comorbidities and assessment of erectile function, intraoperative factors (i.E., incision type, pp model, adjunctive maneuvers) and perioperative / postoperative complications (infection, mechanical malfunction).Results table 1 entire cohort; ams cx 700, 85 (24%); coloplast titan, 264 (75%); ams ambicor, 4 (1%); coloplast genesis, 1 (0.3%); subjective numbness, 29 (8%); infection, 14 (4%) ; mechanical malfunction, 16 (4.5%).Table 2 survey respondents: ams cx 700, 17 (22%) ; coloplast titan, 61 (77%); ams ambicor, 1 (1%); coloplast genesis, 0 (0%); subjective numbness, 6 (8%); mechanical malfunction, 3 (4%); infection, 0 (0%); patient reported satisfaction, 50/57 (88%); conclusion: in our survey of patients who underwent pp placement, the presence of concurrent peyronie¿s disease alone did not impact objective and subjective patient-reported outcomes with penile prosthesis placement.The vast majority of patients with pd were satisfied with their penile straightening after pp alone or in combination with adjunctive maneuvers.However, satisfaction, particularly with penile length, may be impacted by patients with more severe baseline curvature and indentation deformities that require complex adjunctive maneuvers such as incision and grafting.Our findings reinforce the need to adequately counsel patients regarding anticipated outcomes prior to pp placement, particularly in the setting of more severe pd-deformity.

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.Ziegelmann mj, langbo wa, bajic p, levine la.Comparison of patient-reported outcomes after penile prosthesis placement in men with and without peyronie's disease.Int j impot res.2022 aug 29.Doi: 10.1038/s41443-022-00600-5.Epub ahead of print.Pmid: 36038732.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16512963
• MDR Text Key: 311201938
• Report Number: 2125050-2023-00275
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324687
• UDI-Public: 05708932324687
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 5192501400
• Device Catalogue Number: 519250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 03/09/2023
• 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): Other
• Patient Age: 61 YR
• Patient Sex: Male