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

Model Number	1012583-16
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other additional graftmaster is being filed under a separate medwatch report number.Exemption number e2019001.The device will not be returned for evaluation, the device was reportedly discarded.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 patient presented with a free perforation in the proximal left anterior descending coronary artery.Following post-dilatation, the patient developed a coronary perforation, so cpr was performed.A 4.5x26mm graftmaster covered stent delivery system failed to cross due to the anatomy.A 3.5x16mm graftmaster covered stent was deployed but was not confirmed to have sealed the perforation, so a pericardial drain was used to treat the perforation as well.An attempt to insert an impella was made but was unsuccessful due to the anatomy.Despite further cpr, patient in pulseless electrical activity showing no pulse, so the patient was pronounced dead.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 failure to advance 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.

• 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: 9547751
• Report Number: 2024168-2020-00224
• Device Sequence Number: 2314453
• Product Code: MAF
• UDI-Device Identifier: 08717648176470
• UDI-Public: 08717648176470
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/24/2020

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: 06/30/2020
• Device Model Number: 1012583-16
• Device Catalogue Number: 1012583-16
• Device Lot Number: 8073141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/24/2020
• 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: 78 YR