Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture date and expiration date are unknown.Block g2: literature: tenlik, i (2022), pneumatic dilation in geriatric achalasia patients (2022) 19:508-515.Doi: 10.5152/tjg.2023.22178.Block h6: imdrf patient code e2114 captures the reportable event of perforation.
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Boston scientific corporation became aware of multiple events through the article "pneumatic dilation in geriatric achalasia patients" written by ilyas tenlik, et al.According to the literature, between 1995 and 2020 achalasia patients (over the age of 65 and those under the age of 65 as the control group) received pneumatic dilations with rigiflex ii balloons (30, 35 and 40 mm in diameter) and the effectiveness was evaluated.The study included 143 achalasia patients over 65 years of age and 150 achalasia patients under 65 years of age.Mean age of geriatric patients was 72.7 +/- 5.92 (65-90), and 50.3% of them were male.Follow-up was conducted for a mean of 64.52 +/- 38.73 months.Mean age of nongeriatric patients was 43.07 +/- 11.69 (18-63), and 58.7% of them were male.A gradual dilation method was used in the patients and initial dilation was performed with a 30 mm balloon inflated with approximately 10 psi.After 4-6 weeks of dilation, patients were evaluated, and gradual balloon diameter increase (35 or 40mm balloon) treatments were continued if necessary.Balloon related adverse events were observed in two patients.Perforation developed in two of the 293 patients in total.One patient underwent surgical treatment due to the perforation that developed after the first balloon dilation.
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