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

Model Number PFP0.8X8

Device Problem Insufficient Information (3190)

Patient Problem Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to initial reports, patient enrolled in photofix-v study experienced myocardial infarction.

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
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 9383528
• MDR Text Key: 168771521
• Report Number: 1063481-2019-00073
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00877234000553
• UDI-Public: 00877234000553
• Combination Product (y/n): N
• PMA/PMN Number: K172086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening