MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBOZENE MICROSPHERES; EMBOLIC DEVICE

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

Patient Problems Inflammation (1932); Necrosis (1971); Pain (1994)

Event Date 07/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Parkin, cameron james, et al."non-target embolization of the glans penis during prostatic artery embolization." societe internationale d'urologie journal 2.5 (2021): 323-326.

Event Description

It was reported via a journal article that necrosis occurred following embolization.Abstract: prostatic artery embolization is becoming increasingly popular in the management of benign prostatic hyperplasia, particularly for patients with significant comorbidities that make them poor candidates for either general anaesthesia or surgical intervention.Penile tip necrosis as a complication following prostatic artery embolization is exceedingly rare, with only 4 cases previously reported in the world literature.It occurs as a result of the embolization material passing into and occluding collateral arterial networks such as those supplying the glans penis.This paper identifies 3 further cases of penile tip necrosis, outlines its natural history, and proposes management strategies, so that clinicians can better identify and treat this condition.Prostatic artery embolization (pae) is an emerging interventional radiological procedure performed under local anaesthesia, which provides an alternative treatment for benign prostatic hyperplasia (bph) in patients whose preference or medical comorbidities preclude either a general anaesthetic or surgical intervention[1,2].Pae has been shown to improve lower urinary tract symptoms (luts), although not with the same efficacy as a transurethral resection of prostate (turp)[3 - 5].The largest case series reported is of 630 patients, in which 35% of patients reported an immediate improvement in symptoms, 82% had clinical success at medium-term follow-up (1 to 3 years), and 76% had clinical success at long-term follow-up (3 to 6.5 years)[3].Reported complications following pae include dysuria (16.9%) and frequency (11.6%), generally lasting no more than one week, and acute urinary retention (4.6%)[6].Penile tip necrosis as a complication is reported as being exceedingly rare [3,4,6,7].This paper describes 3 cases of penile tip necrosis following pae to enable clinicians to readily identify the complication and manage patients appropriately.

• Brand Name: EMBOZENE MICROSPHERES
• Type of Device: EMBOLIC DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15097757
• MDR Text Key: 296554226
• Report Number: 2134265-2022-08135
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other