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

Model Number SGPH00

Device Problem Crack (1135)

Patient Problem No Code Available (3191)

Event Date 01/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per the initial report, "had multiple cracks when it was thawed and placed in the field.".

Event Description

Per the initial report, "had multiple cracks when it was thawed and placed in the field.".

Manufacturer Narrative

The allograft was returned to cryolife and a sample evaluation was performed.The graft was returned with two cracks in the conduit.The larger of the two cracks was located in the rsc [right semi-lunar cusp] sinus and measured approximately 11mm.The second crack was located proximal to the right pulmonary artery and measured approximately 6mm long.There was no other visual damage to the allograft.A review of processing records was performed and no non-conformances or deviations were identified during this review.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.The issue noted by the complainant may have been caused by mishandling the packaged graft while in the frozen state.The allograft was shipped to (b)(6) via (b)(6) on 12/26/2017 for priority overnight.Prior to the shipment of this allograft, there were no abnormalities noted on the outer packaging.There were no incident reports filed in the courier database for (b)(6) during transit/delivery of this allograft.The ifu provides the following information: "cryopreserved allografts are fragile and must be handled with care while in the frozen state to avoid causing damage to the allograft or packaging," "the patch may be damaged or the integrity of the pouch may be compromised if not properly handled.Do not implant the cryopatch sg:.If after unpacking, the patch was not stored at or below -135°c; if the innermost pouch is damaged, leaks, or is otherwise compromised; if the package has been handled with sharp instruments, dropped while at cryogenic temperatures, or otherwise mishandled, because of the risk of traumatic tissue damage and/ or loss of pouch integrity; if the patch is damaged," "do not damage the patch.If the patch is damaged, the patch must be explanted and replaced," "the cardiac thaw and rinse instructions must be followed exactly to minimize physical damage to the patch," and "cryopatch sg is human biological tissue and, as such, presents considerable anatomical variation.Specific allograft attributes (representing normal biological variation) and donor-specific information are described in the allograft diagram and the certificate of assurance supplied with each allograft.".

• 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
• MDR Report Key: 7290174
• MDR Text Key: 100722458
• Report Number: 1063481-2018-00007
• 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
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/22/2022
• Device Model Number: SGPH00
• Device Catalogue Number: SGPH00
• Device Lot Number: 144673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Distributor Facility Aware Date: 01/26/2018
• Date Manufacturer Received: 01/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other