SYNERGRAFT SGPVOO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-12-22 for SYNERGRAFT SGPVOO manufactured by Cryolife.

Event Text Entries

[2332816] On (b)(6) 2011, the pt underwent planned placement of 25-mm pulmonary valve conduit (synergraft) for the right ventricle to the pulmonary artery. Insp of the graft prior to implantation did not indicate a tear. Pt was successfully weaned from bypass and transferred to picu where he woke up shortly after arrival. He was extubated, awake and conversing with nursing staff. He became tachycardic and shivering. He was given 25 mg of demerol and approx five minutes later, he became hypotensive, arterial line pressure dropped and cvp dropped to approx zero. He was reintubated, resuscitated with fluids, blood product (albumin) and medications (including narcan). Chest compressions were initiated the treatment team lost the pulse. He was taken back to surgery for emergent exploration and repair of tear in pulmonary conduit. Intraop findings included a tear in the pulmonary homograft conduit near the proximal suture line through the friable muscle component of the conduit. During surgery, his pupils became fixed and dilated and an eeg suggested cortical death. He had considerable bleeding and periods of hypotension after coming off bypass. He was made no code after discussion with the family. A repeat eeg early morning of (b)(6) 2011 indicated the pt was clinically dead. He was extubated at 1110 and there was cardiac asystole at 1119.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2396946
• MDR Report Key: 2396946
• Report Source: 99
• Date Received: 2011-12-22
• Date of Report: 2011-12-20
• Date of Event: 2011-12-16
• Date Facility Aware: 2011-12-19
• Report Date: 2011-12-20
• Date Reported to FDA: 2011-12-20
• Date Reported to Mfgr: 2011-12-19
• Date Added to Maude: 2012-01-04
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SYNERGRAFT
• Generic Name: CONDUIT/HOMOGRAPH
• Product Code: OHA
• Date Received: 2011-12-22
• Model Number: SGPVOO
• Catalog Number: SGPVOO
• Lot Number: 113408
• Device Expiration Date: 2016-07-15
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 5 MO
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CRYOLIFE
• Manufacturer Address: KENNESAW GA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2011-12-22