MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number 1012584-19

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Stretched (1601); Device Operates Differently Than Expected (2913); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 4.0x19mm graftmaster device referenced is being filed under a separate medwatch mfr number.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a perforation in the right coronary artery.A 4.0x19mm graftmaster covered stent was successfully implanted, sealing the covered portion of the perforation, however the perforation was very large and the graftmaster was not long enough to cover the entire perforation.The 4.8x19mm graftmaster covered stent was advanced and deployed distal to the previously implanted graftmaster.During removal, the balloon of the 4.8x19mm graftmaster stent delivery system got stuck on the previously implanted graftmaster covered stent and stretched.The tip of the delivery system then separated.It is unclear whether or not the 4.8x19mm graftmaster covered stent successfully sealed the perforation.Pericardiocentesis was performed and then the patient was sent to surgery for coronary artery bypass graft (cabg), during which the separated tip of the 4.8x19mm graftmaster was removed.Although there was a clinically significant delay, post-procedure the patient is doing well.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual inspection was performed on the returned device.The reported stretched material was confirmed.The reported tip detachment could not be confirmed.The reported device being damaged by another device, entrapment of the device and failure to seal the perforation could not be tested as they were based on operational circumstances.The investigation was unable to determine a conclusive cause for the failure to seal the perforation; however, the reported stretched material, detachment of device, entrapment of device, device damaged by another device and the subsequent treatments appear to be related to the circumstances of the procedure.It was reported that the distal stent passed through the proximal stent during implantation.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, instructions for use states: if more than one stent graft is required, the distal stent graft should be placed initially, followed by placement of the proximal stent graft.Stent graft placement in this order obviates the need to cross the proximal stent graft when placing the distal stent graft, and reduces the chances for dislodging the proximal stent graft.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the initial medwatch report, additional information indicates the proximal shaft of the 4.8 x 19 graftmaster separated during removal of the stent delivery system.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 5455882
• MDR Text Key: 38856891
• Report Number: 2024168-2016-01082
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: 1012584-19
• Device Lot Number: 4071841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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): Required Intervention; Disability