MAUDE Adverse Event Report: COLOPLAST A/S TITAN INFLATABLE PENILE PROSTHESIS FAMILY; PENILE PROSTHESIS, INFLATABLE

Catalog Number EN8918

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Insufficient Information (3190)

Patient Problems Erosion (1750); Unspecified Infection (1930); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Title: is a 0% infection rate possible with inflatable penile prosthesis placement? the ten-year results of the minimally invasive no- touch (mint) technique.Author(s): la, justin; katz, darren; shoshany, ohad; lee, elaine; love, christopher.

Event Description

Title: is a 0% infection rate possible with inflatable penile prosthesis placement? the ten-year results of the minimally invasive no- touch (mint) technique.Author(s): la, justin; katz, darren; shoshany, ohad; lee, elaine; love, christopher.Method: as previously described, the infrapubic skin is excluded with both a clear and ioban drape and a three-piece ipp is placed through a 3 cm infrapubic incision facilitated by an alexus wound retractor.A retrospective review of consecutive patients who had primary ipp insertion via the mint technique from (b)(6) 2012 to (b)(6) 2022 from two surgeons with at least three months follow-up were included.This was an unselected cohort, and no exclusions were made based on the aetiology of erectile dysfunction.Patients with adjunct penile procedures were included as long as the ipp was not exposed in a separate incision (e.G.Modelling, glanspexy).Results: a total of 456 patients underwent ipp insertion via the mint technique with a mean followup of 14.0 months.The average age of the cohort was 61.9 10.9 years old.In our cohort, the coloplast titan, coloplast titan narrow base, boston scientific ams 700 lgxtm and boston scientific ams cxtm were placed in 437 (95.8%), 6 (1.3%), 11 (2.4%) and 2 (0.4%) patients respectively.The average length of cylinders inserted was 20.0 2.2 cm and rear tip extenders were used in 323 (70.8%) patients averaging 1.0 0.8 cm.Intraoperative surgical complications included five (1.1%) proximal corporal perforation, four (0.9%) distal corporal perforation, one (0.2%) iliac vein injury and one (0.2%) urethral injury which were all repaired with the appropriate surgical manoeuvers.Post-operatively, scrotal hematoma, urinary retention requiring prolonged catheterisation, superficial wound infection and deep vein thrombosis/ pulmonary embolus was seen in 23 (5.0%), 10 (2.2%), 6 (1.3%) and 5 (1.1%) patients.Six (1.3%) patients had superficial wound or soft tissue infection after ipp insertion which resolved with antibiotics alone.Sixty-eight non-infectious related adjunctive procedures or revisions were performed on 57 (12.5%) patients: 17 mechanical failures, 5 cosmetic, 12 pump relocations, 17 glanspexies, 9 cylinder herniation/malposition, 4 reservoir herniations and 4 distal erosions.There were no infections in patients who did not have intraoperative complications or subsequent ancillary surgeries.Infected ipps requiring salvage or explant were seen in four (0.9%) patients who had uncomplicated primary surgery.Of the four infected ipps, three were due to intraoperative distal perforation and one was due to prolonged primary surgery (intraoperative iliac vein injury and repair).Conclusion: the long-term data on the mint technique for ipp insertion continue to demonstrate the safety of this technique.In this large cohort, there was a 0% infection rate in 388 patients who had an ipp placed via the mint technique and did not have intraoperative complications or additional postoperative procedures.The intraoperative surgical complication rate was 2.4% and the revision rate was 12.5%.

Manufacturer Narrative

Complications reported were erosion, hematoma, infection, migration, perforation, re-surgery, urinary retention, embolism, and thrombosis.The following were reported complications that were identified in the risk management document as possible known harms: erosion, hematoma, infection, migration, perforation, re-surgery, and urinary retention.Embolism and thrombosis were identified as not being listed in risk management documents nor ifu.Based on the clinical assessment, venous thromboembolism (vte; includes deep vein thrombosis (dvt) and pulmonary embolism (pe)) is a blood clot in a vein.It is a well-known postsurgical complication with considerable morbidity, mortality, and economic burden, affecting over 1.2 million americans a year.[snyder 2023] the general risk factors for vte include age, history of cancer, history of vte, heart disease, immobility, obesity, smoking, heart or respiratory failure, and venous varicosities.[geerts 2004] depending on a patient's risk factors for vte, they might be instructed to ambulate early after a procedure, wear compression stockings, receive intermittent pneumatic compression, and/or be treated with prophylactic pharmacologic antithrombotics such as heparin.Risk-stratified thromboprophylaxis guidelines for urologic procedures have been published.[geerts 2004, forrest aua 2009] the risk factors for vte and erectile dysfunction overlap.Habashy et al retrospectively reviewed 215 patients who received ipp surgery and found that 84% of their patient population was classified as high or highest risk for vte on the caprini scale.[habashy 2022] a literature search was conducted in january 2024 for reports of vte in patients who received ipp implants.A retrospective chart review of patients who received penile prostheses reported a death due to pulmonary embolism but no further details were provided.[burns-cox 1997] multiple publications have reported dvt complications due to pelvic vessel (external iliac vein, common femoral vein) compression by an ipp reservoir.[flanagan 1991, da justa 2003, brison 2007, deho 2008, shiraev 2014, kotov 2002] henry et al conducted a cadaver study in 2014 and noted the close proximity of iliac vessels to the space of retzius.[henry 2014] "as such, these structures are at increased risk for iatrogenic injury during prosthesis placement and revision."[van dyke 2021] la et al reported that 5 (1.1%) patients developed deep vein thrombosis/ pulmonary embolus postoperatively.[la 2023] this rate is consistent with the reported rates of vte in urologic surgery, which range from 0.2% to 7.8%; and the rates of vte in ipp surgery, which range from 0.57% to 1.04%.[shakiba 2024, hebert 2022] la et al did not report if the patients who developed vte had a history of thromboembolic complications or risk factors for vte, or if/what type of antithrombotic prophylaxis was used.No corrective action (capa) required at this time.Recommended changes based on clinical assessment to risk documents will be tracked through our post market surveillance meeting (product review).The clinical evaluation report will be updated to assess impact to risk/benefit of the device.

Event Description

Title: is a 0% infection rate possible with inflatable penile prosthesis placement? the ten-year results of the minimally invasive no- touch (mint) technique.Author(s): la, justin; katz, darren; shoshany, ohad; lee, elaine; love, christopher.Method: as previously described, the infrapubic skin is excluded with both a clear and ioban drape and a three-piece ipp is placed through a 3 cm infrapubic incision facilitated by an alexus wound retractor.A retrospective review of consecutive patients who had primary ipp insertion via the mint technique from may 2012 to january 2022 from two surgeons with at least three months follow-up were included.This was an unselected cohort, and no exclusions were made based on the aetiology of erectile dysfunction.Patients with adjunct penile procedures were included as long as the ipp was not exposed in a separate incision (e.G.Modelling, glanspexy).Results: a total of 456 patients underwent ipp insertion via the mint technique with a mean followup of 14.0 months.The average age of the cohort was 61.9 10.9 years old.In our cohort, the coloplast titan, coloplast titan narrow base, boston scientific ams 700 lgxtm and boston scientific ams cxtm were placed in 437 (95.8%), 6 (1.3%), 11 (2.4%) and 2 (0.4%) patients respectively.The average length of cylinders inserted was 20.0 2.2 cm and rear tip extenders were used in 323 (70.8%) patients averaging 1.0 0.8 cm.Intraoperative surgical complications included five (1.1%) proximal corporal perforation, four (0.9%) distal corporal perforation, one (0.2%) iliac vein injury and one (0.2%) urethral injury which were all repaired with the appropriate surgical manoeuvers.Post-operatively, scrotal hematoma, urinary retention requiring prolonged catheterisation, superficial wound infection and deep vein thrombosis/ pulmonary embolus was seen in 23 (5.0%), 10 (2.2%), 6 (1.3%) and 5 (1.1%) patients.Six (1.3%) patients had superficial wound or soft tissue infection after ipp insertion which resolved with antibiotics alone.Sixty-eight non-infectious related adjunctive procedures or revisions were performed on 57 (12.5%) patients: 17 mechanical failures, 5 cosmetic, 12 pump relocations, 17 glanspexies, 9 cylinder herniation/malposition, 4 reservoir herniations and 4 distal erosions.There were no infections in patients who did not have intraoperative complications or subsequent ancillary surgeries.Infected ipps requiring salvage or explant were seen in four (0.9%) patients who had uncomplicated primary surgery.Of the four infected ipps, three were due to intraoperative distal perforation and one was due to prolonged primary surgery (intraoperative iliac vein injury and repair).Conclusion: the long-term data on the mint technique for ipp insertion continue to demonstrate the safety of this technique.In this large cohort, there was a 0% infection rate in 388 patients who had an ipp placed via the mint technique and did not have intraoperative complications or additional postoperative procedures.The intraoperative surgical complication rate was 2.4% and the revision rate was 12.5%.

Event Description

Title: is a 0% infection rate possible with inflatable penile prosthesis placement? the ten-year results of the minimally invasive no- touch (mint) technique.Author(s): la, justin; katz, darren; shoshany, ohad; lee, elaine; love, christopher.Method: as previously described, the infrapubic skin is excluded with both a clear and ioban drape and a three-piece ipp is placed through a 3 cm infrapubic incision facilitated by an alexus wound retractor.A retrospective review of consecutive patients who had primary ipp insertion via the mint technique from may 2012 to january 2022 from two surgeons with at least three months follow-up were included.This was an unselected cohort, and no exclusions were made based on the aetiology of erectile dysfunction.Patients with adjunct penile procedures were included as long as the ipp was not exposed in a separate incision (e.G.Modelling, glanspexy).Results: a total of 456 patients underwent ipp insertion via the mint technique with a mean followup of 14.0 months.The average age of the cohort was 61.9 10.9 years old.In our cohort, the coloplast titan, coloplast titan narrow base, boston scientific ams 700 lgxtm and boston scientific ams cxtm were placed in 437 (95.8%), 6 (1.3%), 11 (2.4%) and 2 (0.4%) patients respectively.The average length of cylinders inserted was 20.0 2.2 cm and rear tip extenders were used in 323 (70.8%) patients averaging 1.0 0.8 cm.Intraoperative surgical complications included five (1.1%) proximal corporal perforation, four (0.9%) distal corporal perforation, one (0.2%) iliac vein injury and one (0.2%) urethral injury which were all repaired with the appropriate surgical manoeuvers.Post-operatively, scrotal hematoma, urinary retention requiring prolonged catheterisation, superficial wound infection and deep vein thrombosis/ pulmonary embolus was seen in 23 (5.0%), 10 (2.2%), 6 (1.3%) and 5 (1.1%) patients.Six (1.3%) patients had superficial wound or soft tissue infection after ipp insertion which resolved with antibiotics alone.Sixty-eight non-infectious related adjunctive procedures or revisions were performed on 57 (12.5%) patients: 17 mechanical failures, 5 cosmetic, 12 pump relocations, 17 glanspexies, 9 cylinder herniation/malposition, 4 reservoir herniations and 4 distal erosions.There were no infections in patients who did not have intraoperative complications or subsequent ancillary surgeries.Infected ipps requiring salvage or explant were seen in four (0.9%) patients who had uncomplicated primary surgery.Of the four infected ipps, three were due to intraoperative distal perforation and one was due to prolonged primary surgery (intraoperative iliac vein injury and repair).Conclusion: the long-term data on the mint technique for ipp insertion continue to demonstrate the safety of this technique.In this large cohort, there was a 0% infection rate in 388 patients who had an ipp placed via the mint technique and did not have intraoperative complications or additional postoperative procedures.The intraoperative surgical complication rate was 2.4% and the revision rate was 12.5%.

Manufacturer Narrative

According to the available information, the article reported clinical research that occurred in the united states.Complications reported were erosion, hematoma, infection, migration, perforation, re-surgery, urinary retention, embolism, and thrombosis.The following were reported complications that were identified in the risk management document as possible known harms: erosion, hematoma, infection, migration, perforation, re-surgery, and urinary retention.Embolism and thrombosis were identified as not being listed in risk management documents nor ifu.Based on the clinical assessment, venous thromboembolism (vte; includes deep vein thrombosis (dvt) and pulmonary embolism (pe)) is a blood clot in a vein.It is a well-known postsurgical complication with considerable morbidity, mortality, and economic burden, affecting over 1.2 million americans a year.[snyder 2023] the general risk factors for vte include age, history of cancer, history of vte, heart disease, immobility, obesity, smoking, heart or respiratory failure, and venous varicosities.[geerts 2004] depending on a patient's risk factors for vte, they might be instructed to ambulate early after a procedure, wear compression stockings, receive intermittent pneumatic compression, and/or be treated with prophylactic pharmacologic antithrombotics such as heparin.Risk-stratified thromboprophylaxis guidelines for urologic procedures have been published.[geerts 2004, forrest aua 2009].The risk factors for vte and erectile dysfunction overlap.Habashy et al retrospectively reviewed 215 patients who received ipp surgery and found that 84% of their patient population was classified as high or highest risk for vte on the caprini scale.[habashy 2022] a literature search was conducted in january 2024 for reports of vte in patients who received ipp implants.A retrospective chart review of patients who received penile prostheses reported a death due to pulmonary embolism but no further details were provided.[burns-cox 1997] multiple publications have reported dvt complications due to pelvic vessel (external iliac vein, common femoral vein) compression by an ipp reservoir.[flanagan 1991, da justa 2003, brison 2007, deho 2008, shiraev 2014, kotov 2002] henry et al conducted a cadaver study in 2014 and noted the close proximity of iliac vessels to the space of retzius.[henry 2014] "as such, these structures are at increased risk for iatrogenic injury during prosthesis placement and revision."[van dyke 2021].La et al reported that 5 (1.1%) patients developed deep vein thrombosis/ pulmonary embolus postoperatively.[la 2023] this rate is consistent with the reported rates of vte in urologic surgery, which range from 0.2% to 7.8%; and the rates of vte in ipp surgery, which range from 0.57% to 1.04%.[shakiba 2024, hebert 2022] la et al did not report if the patients who developed vte had a history of thromboembolic complications or risk factors for vte, or if/what type of antithrombotic prophylaxis was used.No corrective action (capa) required at this time.Recommended changes based on clinical assessment to risk documents will be tracked through our post market surveillance meeting (product review).The benefit/risk will be assessed based upon risk documentation.

• Brand Name: TITAN INFLATABLE PENILE PROSTHESIS FAMILY
• Type of Device: PENILE PROSTHESIS, INFLATABLE
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18518578
• MDR Text Key: 332933535
• Report Number: 2125050-2024-00083
• Device Sequence Number: 1
• Product Code: FHW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000006
• 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,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: EN8918
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 62 YR
• Patient Sex: Male