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

Catalog Number 1012580-19

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the graftmaster stent was used to treat a perforation that occurred in the right coronary artery with the use of an unspecified device but failed to deploy and was not implanted.A different graftmaster stent was successfully implanted as treatment of the perforation.There was no reported adverse patient sequela.There was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).The other graftmaster referenced is filed under a separate medwatch mfr number.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.It has been determined that the reported failure to advance and subsequent treatment appear to be related to circumstances of the procedure.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 did not indicate a lot specific quality issue.It should be noted that the graftmaster coronary stent graft system instructions for use (ifu) states: an unexpanded stent graft should not be reintroduced into the artery once it has been pulled back into the guiding catheter.Subsequent movement in and out through the distal end of the guiding catheter should not be performed, as the stent graft may be damaged when retracting the un-deployed stent graft back into the guiding catheter.It should also be noted that the ifu 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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial medwatch report filed, additional information was received stating that the graftmaster (gm) stent was advanced but failed to cross the previously implanted gm.The device was removed and additional balloon dilatation completed, then the same gm attempted to cross again but failed and was removed.After additional balloon dilatation an unspecified bare metal stent was implanted as treatment of the perforation.There was no reported adverse patient sequela.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: 5464733
• MDR Text Key: 39196303
• Report Number: 2024168-2016-01180
• 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: 03/10/2016

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: 02/28/2017
• Device Catalogue Number: 1012580-19
• Device Lot Number: 5032641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 81 YR
• Patient Weight: 64