MAUDE Adverse Event Report: ABBOTT VASCULAR GRAFTMASTER; CORONARY STENT DELIVERY SYSTEM

Model Number	1012580-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a pre-existing perforation in the mid-left anterior descending artery.The 2.50x26mm graftmaster stent delivery system failed to cross a non-abbott stent.The perforation was sealed with bypass surgery.There was no adverse patient sequela reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported failure to advance could not be tested as it was based on operational circumstances.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.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.B5: the graftmaster size is 2.80 not 2.50.No change to d4.
Event or Problem Description
Correction: the graftmaster size is 2.80, not 2.50.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9934012
• Report Number: 2024168-2020-03451
• Device Sequence Number: 701708
• Product Code: MAF
• UDI-Device Identifier: 08717648176364
• UDI-Public: 08717648176364
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 1012580-26
• Device Catalogue Number: 1012580-26
• Device Lot Number: 8103141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEZILLA; SYNERGY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Weight: 104