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

Catalog Number	1012582-26
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer reported the stent remains in patient.A follow-up report will be submitted with all additional relevant information.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the proximal right coronary artery.A 4.0 x 26 mm graftmaster covered stent was implanted; however, it failed to seal it.The patient then experienced cardiac arrest and expired.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for evaluation.It was initially reported that the procedure was to treat a perforation in the proximal right coronary artery.A 4.0 x 26 mm graftmaster covered stent was implanted; however, it failed to seal it.The patient then experienced cardiac arrest and expired on (b)(6) 2019, the same day as the procedure date.Subsequent to the initial report, additional information was received.The perforation was larger than anticipated and the graftmaster covered stent sealed the perforation where it was implanted.There were no device issues with the device, and it did not cause or contribute to the death.The cause of death was hemopericardium; however, as the initial report was already filed, this must remain reportable and filed as a death report.No investigation required.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.Adverse event or product problem - adverse patient effects and product problem boxes unchecked.Outcomes attributed to adverse event - outcomes attributed to ae: updated from death to na.Mfr site - contact office first and last name was updated from connie speck to lindsey bell.Type of reportable event - death box unchecked.Patient codes 1802 (death) and 1762 (cardiac arrest) were removed and 2199 was added.Device code 2682 (patient-device incompability) was removed and 2993 was added.
Event or Problem Description
It was reported that the procedure was to treat a perforation in the proximal right coronary artery.A 4.0 x 26 mm graftmaster covered stent was implanted; however, it failed to seal it.The patient then experienced cardiac arrest and expired on (b)(6) 2019, the same day as the procedure date.Subsequent to the inital report, additional information was received.The perforation was larger than anticipated and the graftmaster covered stent sealed the perforation where it was implanted.There were no device issues with the device, and it did not cause or contribute to the death.The cause of death was hemopericardium.No additional information was provided.

• 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: 8787053
• Report Number: 2024168-2019-10071
• Device Sequence Number: 16743630
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 06/30/2019
• Device Catalogue Number: 1012582-26
• Device Lot Number: 7071141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 10/03/2019
• 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: Death
• Patient Age: 77 YR
• Patient Weight: 117