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Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Lock b3: approximated based on the year the first procedures were performed.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block e1: initial reporter facility name: (b)(6) hospital block g2 (literature source): journal article: orel carmona, et al, 'unveiling the challenges in tandem ureteral stent management for malignant ureteral obstruction: failure rate, risk factors, and durability of their replacement'.J.Clin.Med 2023, 12, 5251 block h6: imdrf device code a1409 captures the reportable event of stent obstructed.
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Event Description
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Boston scientific corporation became aware of the event through the article "unveiling the challenges in tandem ureteral stent management for malignant ureteral obstruction: failure rate, risk factors, and durability of their replacement", orel carmona, asaf shvero, dorit e.Zilberman, zohar a.Dotan, and nir kleinmann.Per the article, 186 patients being treated for malignant ureteral obstruction (muo) received 240 tandem ureteral stent (tus) placements.The patients underwent stenting between 2014 and 2022, then replacement procedures after 12 months.Follow up visits were performed 1 month after stenting then every 2 months thereafter.During the procedures, 2 stents would be placed simultaneously over guidewire under fluoroscopy.The procedures were performed under general anesthesia in the dorsal lithotomy position.In 67 patients, drainage of the stent failed.
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Search Alerts/Recalls
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