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

Catalog Number 1012818-26

Device Problems Positioning Failure (1158); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the patient presented with a perforation in the 90% stenosed and calcified mid left anterior descending (lad) coronary artery.A 3.5x26mm rx graftmaster covered stent system was advanced without resistance to the target area then the system was pressurized to an unspecified pressure; the delivery system was unable to be inflated to nominal pressure, the stent graft only partially expanded, and stent graft was confirmed to be in a dog-bone shape and was not apposed to the vessel wall.The rx graftmaster delivery system was completely deflated.As the stent graft was partially expanded, but not dislodged from the balloon, as a precaution, a snare device was used during withdrawal of the graftmaster to prevent stent dislodgement; the entire device was successfully withdrawn from the anatomy; no leak was noted on the device.The perforation was sealed via dilatation with an unspecified perfusion balloon.There were no adverse patient sequelae and no occurrence of a clinically significant delay.The abbott vascular returned goods lab received the device with its proximal shaft separated and was not returned.Additional information received confirmed that the correct device was returned and that the site had intentionally cut the proximal shaft off of the device after removal from the anatomy in order to pull the device distally out of the guiding catheter; this proximal piece was discarded.No additional information was provided.

Manufacturer Narrative

(b)(4).A visual inspection was performed on the returned device.The reported inflation issue and failure to deploy could not be tested due to the device condition as the proximal separated portion of the hypotube along with the hub were not returned.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 other incidents.The investigation was unable to determine a conclusive cause for the reported inflation issue and failure to deploy.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.

• 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: 6400838
• MDR Text Key: 69821512
• Report Number: 2024168-2017-02069
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1012818-26
• Device Lot Number: 6111041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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