[178303116]
Event verbatim [preferred term] treatment by absorbable gelatin sponge and microcoil embolization after perforation of the distal coronary artery by guidewire [product use in unapproved indication] , foreign body reaction [foreign body reaction] ,. Case narrative:this is a literature-spontaneous report from internal medicine, (2010), (49(17)) (1871-1874) entitled [foreign body granulomatous change from absorbable gelatin sponge and microcoil embolization after a guidewire-induced perforation in the distal coronary artery]. A contactable other hcp reported for a patient that: we report an autopsy case of treatment by absorbable gelatin sponge and microcoil embolization after perforation of the distal coronary artery by guidewire. Histological examination revealed a foreign body granuloma in the coronary artery with embolization. Foreign body reaction to absorbable gelatin sponge seemed to be stronger than that to the microcoil. Additional information has been requested and will be provided as it becomes available. Company clinical evaluation comment: absorbable gelatin sponge used intravascular is contraindicated, and the reported foreign body granulomatous change was associated it. It was unknown whether the underlying perforation of the distal coronary artery by guidewire was the cause of death, or the foreign body granulomatous change in coronary artery attributed to patient's death. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate. , comment: absorbable gelatin sponge used intravascular is contraindicated, and the reported foreign body granulomatous change was associated it. It was unknown whether the underlying perforation of the distal coronary artery by guidewire was the cause of death, or the foreign body granulomatous change in coronary artery attributed to patient's death. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the pfizer product is evaluated as part of pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
Patient Sequence No: 1, Text Type: D, B5