MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOPATCH SYNERGRAFT PULMONARY HEMI-ARTERY; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number SGPH00

Device Problem Material Separation (1562)

Patient Problems Not Applicable (3189); No Code Available (3191)

Event Date 11/15/2018

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 an email received on 11/16/2018: "implanted the hemi artery patch on the aortic arch.Took clamp off, pressure went to 40, center of the patch "apperared" to delaminate.Used additional patch from the same hemi artery to buttress and patch over the original patch." a phone call was made to representative on 11/20/2018 to request if the patient remained stable throughout the procedure, current patient status, and if the doctor noticed anything prior to implant that could have lead to the reported event.The representative replied: "the patient did remain stable throughout the procedure and it was successful.The doctor did not notice anything that could have led to the reported event.".

Event Description

According to an email received on 11/16/2018: "implanted the hemi artery patch on the aortic arch.Took clamp off, pressure went to 40, center of the patch apperared to delaminate.Used additional patch from the same hemi artery to buttress and patch over the original patch." a phone call was made to representative on 11/20/2018 to request if the patient remained stable throughout the procedure, current patient status, and if the doctor noticed anything prior to implant that could have lead to the reported event.The representative replied: "the patient did remain stable throughout the procedure and it was successful.The doctor did not notice anything that could have led to the reported event." a phone call was made to the representative on 11/22/2018 to request operative notes for the event."i have gotten all the information that i can," was the reply.

Manufacturer Narrative

Sample was returned form [facility] and examined on 11/29/2018.A root cause could not be determined as the graft met all specifications and no delamination occurred when the subject matter expert manipulated the tissue.All attributes identified during inspection were documented appropriately, no non-conformances were noted, and no findings were identified that could have contributed to the reported event.During the inspection of each cardiac graft, a qualified inspector wearing surgical loupes inspects the graft noting any attributes such as holes, tears, disruptions, plaque, etc.According to the processing records, this graft did not contain any attributes that would have rejected the graft.The risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.Post production residual risk is communicated in the product's labeling and ifu [instructions for use].No root cause could be identified in the manufacturer's review and all risk are identified.No action necessary.This event does not identify additional hazards or modify the probability and severity of existing hazards.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.  furthermore, this report reflects the event as alleged by the complainant and does not imply that the information required to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: CRYOPATCH SYNERGRAFT PULMONARY HEMI-ARTERY
• Type of Device: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8155308
• MDR Text Key: 130057423
• Report Number: 1063481-2018-00053
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K091626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SGPH00
• Device Catalogue Number: SGPH00
• Device Lot Number: 145686
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other