MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW PHOTOFIX PATCH - 0.8CM X 8CM; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number	PFP0.8X8
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
Event or Problem Description
According to initial reports, patient enrolled in photofix-v study experienced myocardial infarction.
Additional Manufacturer Narrative
According to ecrfs, patient participant in photo-v study, presented with persistent chest pain, troponin 12.29.He also had an mi end of september.Prior coronary interventions in (b)(6) 2018, (b)(6) 2019.Left cea on (b)(6) 2019.Angiogram at this hospitalization demonstrated severe re-narrowing of lad stents and additional atherectomy and stenting was required.Patient discharged home next day on brilinta and aspirin.Of note, the patient does state he stopped taking his aspirin for 1 month in (b)(6) 2019.This review is relegated to the (b)(6) 2019 cardiac event.The event was categorized as a serious adverse event ¿ non-product related.The product was not noted to have contributed to the reported event.There is no alleged deficiency toward the product.An investigation for this event is not required at this time.

• Brand Name: PHOTOFIX PATCH - 0.8CM X 8CM
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 9383528
• Report Number: 1063481-2019-00073
• Device Sequence Number: 2219368
• Product Code: DXZ
• UDI-Device Identifier: 00877234000553
• UDI-Public: 00877234000553
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K172086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 12/31/2020
• Device Model Number: PFP0.8X8
• Device Lot Number: 31011019
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/04/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 11/04/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening