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

Model Number SGPH00

Device Problem Material Integrity Problem (2978)

Patient Problem Blood Loss (2597)

Event Date 06/14/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information received, " [person initiating report] received an email this morning stating that [doctor's] last 2 [products] used for norwood procedures were falling apart and were not ideal for sewing." the surgeon has stated via email "what i have been experiencing is significant suture-line bleeding from what appears to be poor tissue integrity.I am becoming concerned the [product] technology may be making thin pa tissue a bit easy for sutures to pull through the tissue when under tension.Currently [it is] an observation but happening enough to concern me with long patches placed deep as with norwood procedures.".

Manufacturer Narrative

Date of event: (b)(6) 2017, the patient has been discharged home and is stable.Date of implant: (b)(6) /2017.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Information received, " [person initiating report] received an email this morning stating that [doctor's] last 2 [products] used for norwood procedures were falling apart and were not ideal for sewing." the surgeon has stated via email "what i have been experiencing is significant suture-line bleeding from what appears to be poor tissue integrity.I am becoming concerned the [product] technology may be making thin pa tissue a bit easy for sutures to pull through the tissue when under tension.Currently [it is] an observation but happening enough to concern me with long patches placed deep as with norwood procedures." the patient has been discharged home and is stable.

Manufacturer Narrative

A review of processing records was performed and no non-conformances or deviations were identified during this review.Graft 10832784 was not returned to cryolife so no direct observations could be made.According to the processing records, this graft did not contain any attributes that would have rejected the graft.All attributes noted during inspection of the allograft were documented appropriately and the allograft met specifications.A review of training records indicates that the technician who inspected this allograft at packaging was appropriately trained for the task performed.There is insufficient information available to determine the root cause of the reported event.This event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

Information received, " [person initiating report] received an email this morning stating that [doctor's] last 2 [products] used for norwood procedures were falling apart and were not ideal for sewing." the surgeon has stated via email "what i have been experiencing is significant suture-line bleeding from what appears to be poor tissue integrity.I am becoming concerned the [product] technology may be making thin pa tissue a bit easy for sutures to pull through the tissue when under tension.Currently [it is] an observation but happening enough to concern me with long patches placed deep as with norwood procedures." the patient has been discharged home and is stable.

• Brand Name: CRYOPATCH SG 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
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd, nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd nw; kennesaw, GA 30144
• MDR Report Key: 6762994
• MDR Text Key: 81694764
• Report Number: 1063481-2017-00027
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/01/2021
• Device Model Number: SGPH00
• Device Catalogue Number: SGPH00
• Device Lot Number: 138048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/05/2017
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other