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

Catalog Number	1012583-19
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	06/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was 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.The reported patient effect of pseudoaneurysm is listed in the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use (ifu) as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
Event or Problem Description
It was reported that the patient presented with a right coronary artery (rca) pseudoaneurysm located at a previous implanted rca stent and with a coronary femoral fistula into the right atrium.A 4.5x19mm graftmaster stent was implanted without reported issue in the pseudoaneurysm area with the perforation.Subsequent angiography revealed improved blood flow in this area; however, there was continued pseudoaneurysm formation.Reportedly, the perforation was sealed; however, it is unknown if the graftmaster stent contributed to the continued pseudoaneurysm formation.A 4.0x8mm non-abbott stent was implanted in the mid rca, overlapping the previous graftmaster stent.Additionally, a 4.0x8mm xience alpine stent was implanted overlapping the distal portion of the graftmaster stent.Post dilatation was performed on the entire stented portion.Final imaging revealed excellent stent apposition and exclusion of the pseudoaneurysm area with brisk antegrade flow distally.The patient tolerated the procedure well with no adverse sequela.Per physician, the graftmaster stent did not cause or contribute to complications or adverse events.There was no additional information provided regarding this device issue.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6440349
• Report Number: 2024168-2017-02603
• Device Sequence Number: 11009650
• Product Code: MAF
• UDI-Device Identifier: 08717648176487
• UDI-Public: (01)08717648176487(17)171130(10)5120441
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 1012583-19
• Device Lot Number: 5120441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2017
• Initial Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 122