Literature citation: yoshiharu kawaguchi,m.D.,p h.D."balloon kypltoplasty : surgical results, efficacy and limitations".Average age: 77 years.Sex: female (male: 252; female:763).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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