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

Catalog Number 1012581-19

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 patient presented with a free perforation with extravasation in the proximal right coronary artery (rca).After inserting a 3.5x19 rx graftmaster stent graft for treatment of the perforation, blood throughout the length of its delivery catheter was noted; thus, this graftmaster was withdrawn, undeployed.A 4.0x19 rx graftmaster stent graft was deployed in the proximal rca perforation with a maximum pressure of 14 atmospheres, successfully sealing the perforation.Reportedly, use of both graftmasters did not cause or contribute to complications or adverse events.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual and functional inspection was performed on the returned device.The reported kinked (shaft and proximal shaft) and leak were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to circumstances of the procedure.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 filed medwatch report, additional information was received as is reflected in the following revised case description: it was reported that the patient presented with angina and a free perforation with extravasation in the proximal right coronary artery (rca).A 3.5x19 rx graftmaster stent graft was unpackaged without issue when the shaft was noted to be kinked in two places on the proximal shaft near the hub.Upon advancing the 3.5x19 rx graftmaster stent graft to the perforation site without resistance, with negative pressure pulled using an inflation device, blood was noted at the hub of the graftmaster and throughout the length of the delivery catheter; the leak originated from a distal shaft kink.Thus, this graftmaster was withdrawn without difficulty, undeployed.A 4.0x19 rx graftmaster stent graft was deployed in the proximal rca perforation with a maximum pressure of 14 atmospheres, successfully sealing the perforation.There were no adverse patient sequelae and no occurrence of a clinically significant delay.No additional information was provided.

• 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: 5880781
• MDR Text Key: 52274428
• Report Number: 2024168-2016-05466
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1012581-19
• Device Lot Number: 6051641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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
• Patient Age: 75 YR
• Patient Weight: 90