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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEMOSPHERE, INC. HERO GRAFT; VASCULAR GRAFT, PROSTHESIS
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HEMOSPHERE, INC. HERO GRAFT; VASCULAR GRAFT, PROSTHESIS Back to Search Results
Model Number HERO 1002
Device Problem Kinked (1339)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
According to the report, the surgeon mentioned that he had 5 or 6 patients who experienced hero graft kinking where the beading meets the graft at the connector.The surgeon stated that he thinks there is something to do with the graft portion itself.The surgeon found the kinking through open surgery thrombectomies.This report represents one of the events.
 
Manufacturer Narrative
This investigation is currently ongoing.Any additional information will be provided in the follow-up report.
 
Manufacturer Narrative
According to the report, the surgeon mentioned that he had at least 5 or 6 patients who experienced hero graft kinking where the beading meets the graft at the connector.The surgeon did not have lot numbers to provide as "product is constantly moving around the facility." the surgeon found the kinking through open surgery thrombectomies.Several attempts were made to contact the surgeon for additional information regarding this event: contact via cryolife representative on 6/09/2014, one tracked letter sent on 9/15/2014, one email sent on 10/03/2014, and one fax sent on 11/10/2014.Additional information was requested from the surgeon regarding implant location of the connector, precautions taking to minimize kinking, whether grafts from other manufacturers were used, and possible lot numbers.These questions were asked as kinking can occur as a result of connector position or if a different type graft is attached to the hero graft.A response was not received from the surgeon.If additional information is received the complaint will be re-opened for further investigation.The surgeon has indicated that he is unable to provide lot numbers.The date of the event is unknown and there is no definitive date range to determine possible lot numbers from.A clinical and medical review of this event was performed.Two images were received on 6/13/2014 from the cryolife representative.One image had a date of 2/28/2014, however, there is no indication of what this date represents and no clarification was received.Both images appear to be a photograph of a fluoroscopy screen for one patient and a printed fluoroscopy image for another patient.Both images show disruption in flow around the area where the beaded section of the eptfe ends, which matches the surgeon's description of "kinking where the beading meets the graft at the connector." the dates of implants are unknown.Lot numbers were not provided.In september 2012, distribution of the agc manufacturing with "d"-beading began; prior to september 2012, the agc was manufactured with a "wrapped" beading.Without the lot numbers, it cannot be confirmed that this incident involved d-beaded eptfe graft material.The beading is intended to provide kink resistance near the connector but cannot prevent all device kinking.Device kinking or compression is listed in the hero graft instructions for use (ifu) as a potential complication.The ifu instructs to "utilize the markings on the arterial graft component to verify it has not twisted." the ifu also contains cautions in reference to the beading and possible beading damage in the section on implanting the arterial graft component (agc): "do not grasp, peel, or otherwise damage the arterial graft component beads as this may adversely impact the integrity of the graft.It is important during device connection to grasp the silicone sleeve of the arterial graft component and avoid contact with the beading.Ensure the beading is not crushed or damaged." "if damage to the beading is noted during implant, a new arterial graft component should be used." "damage or crushed beading may lead to flow disruption within the hero graft, and may contribute to early device occlusion and/or repeated occlusion." since the operative notes are not available, it is not possible to further investigate the relationship of the hero graft implant technique or implanted location to the adverse event.While a definitive root cause cannot be determined, kinking represents a known potential complication of the hero graft which is outlined in the device's ifu.The ifu provides precautions and warnings about avoiding damage to the beading of the graft to decrease the likelihood of kinking.There is no indication that an error or deficiency occurred at cryolife.
 
Event Description
According to the report, the surgeon mentioned that he had 5 or 6 patients who experienced hero graft kinking where the beading meets the graft at the connector.The surgeon stated that he thinks there is something to do with the graft portion itself.The surgeon found the kinking through open surgery thrombectomies.This report represents one of the events.
 
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Brand Name
HERO GRAFT
Type of Device
VASCULAR GRAFT, PROSTHESIS
Manufacturer (Section D)
HEMOSPHERE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
Manufacturer (Section G)
HEMOSPHERE, INC.
1655 roberts blvd. nw
kennesaw GA 30144
Manufacturer Contact
sandra o'reilly
1655 roberts blvd., nw
kennesaw, GA 30144
7704193355
MDR Report Key3919916
MDR Text Key4493621
Report Number3006945290-2014-00048
Device Sequence Number1
Product Code DSY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Model NumberHERO 1002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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