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Event verbatim [preferred term] pulmonary infarction [pulmonary infarction].This is a spontaneous report from a contactable physician.A patient of unspecified age and gender started to receive absorbable gelatin (gelfoam), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.Medical history included arteriovenous malformation (av malformation) from an unknown date and unknown if ongoing.There were no relevant drug history, drug or alcohol abuse, drug allergies or family history.The patient's concomitant medications were not reported.The patient experienced pulmonary infarction on an unspecified date.Symptoms started immediately after.Event occurred several hours after cessation of treatment.The action taken in response to the event for absorbable gelatin was not applicable.Therapeutic measures were taken as a result of pulmonary infarction (pulmonary support).The patient died on an unspecified date.It was not reported if an autopsy was performed.The reporter stated that this happened maybe 30 years ago.No follow up attempts are possible.No further information is expected.Based on information available, the reported pulmonary infarction was probably associated with the use of absorbable gelatin (gelfoam), due to temporal relationship.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: based on information available, the reported pulmonary infarction was probably associated with the use of absorbable gelatin (gelfoam), due to temporal relationship.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.
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Event verbatim [preferred term] pulmonary infarction [pulmonary infarction] ,.Case narrative:this is a spontaneous report from a contactable physician.A patient of unspecified age and gender started to receive absorbable gelatin (gelfoam), via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication.Medical history included arteriovenous malformation (av malformation) from an unknown date and unknown if ongoing.There were no relevant drug history, drug or alcohol abuse, drug allergies or family history.The patient's concomitant medications were not reported.The patient experienced pulmonary infarction on an unspecified date.Symptoms started immediately after.Event occurred several hours after cessation of treatment.The action taken in response to the event for absorbable gelatin was not applicable.Therapeutic measures were taken as a result of pulmonary infarction (pulmonary support).The patient died on an unspecified date.It was not reported if an autopsy was performed.The reporter stated that this happened maybe 30 years ago.On 08jun2019, the product quality complaints group provided the following investigation summary: product desc: gelfoam sterile sponge size 50 x 4.Product country: usa.Sap/unique identifier : (b)(4).Classification: external cause investigation.Subclass: adverse event safety request for investigation, sample status: not available.Lot number: unknown.Lot number unknown reason: not provided in correspondence/email communication.Udi: (b)(4).Scope: all gelfoam sponge and gelfoam powder batches produced within the 36 months prior to the receipt of the reported complaint were queried within pcom, and all complaints found were examined against the reported complaint narrative and complaint classification.One previous complaint with a known batch number was determined to be within scope: # - us (l63414).Returned product examination: pgs (site name redacted) did not receive a returned complaint sample, or photographs, for evaluation.Reference sample examination: complete - acceptable.A reference sample examination was performed for the complaint with a known batch number listed above.A review of the examination determined that the amount of product present was acceptable, and that no quality defects were observed in the course of the exam.Deviations: complete - acceptable.Deviations, laboratory investigation reports (lir), and change management records for all batches in aprrs and the site deviation tracking system for 36 months prior to the receipt of the reported complaint were reviewed.Packaging records: complete - acceptable.A review of manufacturing records was performed as a part of the complaint with a known batch numbers listed above.A review of the report determined that the manufacturing records were acceptable, and that no quality issues were present.Process control evaluation: existing process controls were reviewed as a part of this investigation.The review determined that the process controls were appropriate and acceptable; therefore the medical device qop was not notified.Qo batch history report: complete - acceptable.Per review of the aprr reports over the expiry interval reaching back from the receipt of the compliant, there were no batches produced with analytical testing results that were outside of registered specifications prior to release.A review of the complaint determined to be within scope demonstrated that all tests and inpections passed prior to release of the involved batch.Medical device report review: a review of all previous medical device reports (mdr) was performed as a part of this investigation.Previous mdr relevant to the reported complaint had been issued by safety; therefore, the reported complaint was escalated to pfizer us for further evaluation of mdr.Batch specific trend review: complete - acceptable.The batch number for the reported complaint is unknown; therefore, an evaluation of the batch history could not be performed as a part of this investigation.Medical device trend analysis: complete - acceptable.The complaint history for products with the product category defined as 'absorbable material - foam' and 'absorbable material - powder' has been reviewed.The following parameters were used:- product category: absorbable material - foam and absorbable material-powder.Time period: 15oct2014 - 31may2019.Complaint classification: external cause investigation, investigating site: pfizer (site name redacted).An expanded time period and product category scope was used for the analysis of trending to capture complaints that have been received by pfizer (site name redacted) as a result of a remediation effort by pfizer us safety, their full range of complaint contact dates, and the associated product expiry windows.The results of the above query were evaluated by date contacted and by the classification of external cause investigation.There were two months (april and may2019) that included a higher than normal number of complaints; however, this is due to the remediation effort noted above.Additionally, the results from the query were evaluated by the sub-class of 'adverse event safety request for investigation,' and there were two months (april and may2019) that included a higher than normal number of complaints, also as a result of remediation by pfizer us safety.No trend was observed that would require further investigations.Root cause: pfizer (site name redacted) quality operations could not determine a root cause for the reported defect to be related to the (site name redacted) production process.A review of the aprr reports, the previously investigated complaint report, and an evaluation of trends indicated that all gelfoam batches relevant to this investigation had met established requirements at the time of release.It is unknown how the reported complaint sample was handled, stored, or used after leaving the pfizer (site name redactive) site.Corrective action: there were no corrective actions identified as a result of this complaint investigation.All reviewed records, previous investigations, trends, and in-process controls were acceptable, and have met the established requirements.Quality of batch: acceptable.The worst case severity could not be determined through a review of the device risk file for the product; therefore, the details of the reported complaint were forwarded to pfizer safety for evaluation of regulatory reportability.Additionally, the details of the complaint have been forwarded to the mdcp team for review.Based upon the results of this investigation, pgs-qo (site name redacted) concludes that the quality of the product on the market remains acceptable.Conclusion: the review of all records and reports within scope of this investigation demonstrated the acceptability of the product over the timeframe within scope.No product quality issues were observed.No follow up attempts are possible.No further information is expected.Follow-up (08jun2019): new information reported from the product quality complaints group includes: investigation summary.No follow up attempts are possible.No further information is expected.Based on information available, the reported pulmonary infarction and subsequent death was probably associated with the use of absorbable gelatin (gelfoam), due to temporal relationship.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: based on information available, the reported pulmonary infarction and subsequent death was probably associated with the use of absorbable gelatin (gelfoam), due to temporal relationship.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.
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