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

Catalog Number	1012582-26
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132); Pericardial Effusion (3271)
Date of Event	10/10/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
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.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 did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported failure to seal and the reported patient effects.A relationship to the product, if any, cannot be determined.The reported patient effects of hypotension, ventricular fibrillation, ventricular tachycardia and death as listed in the graftmaster rx coronary stent graft system, instructions for use, are known patient effects that may be associated with use of a coronary stent in native coronary arteries.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient went into cardiac arrest after the mid left anterior descending (mlad) coronary artery was treated percutaneously.The 4.0x26 mm graftmaster stent was implanted in the mlad coronary artery to treat a vessel perforation in the mlad.The graftmaster was deployed during cardiopulmonary resuscitation (cpr) which made it a challenge because of the activities of cpr and movement.After the graftmaster was deployed, prolonged balloon inflation was performed along with pericardiocentesis.The graftmaster did not seal the perforation.The patient had a complete loss of blood pressure and was unable to be resuscitated.The patient's cardiac rhythms progressed from pulseless electrical activity to ventricular tachycardia to ventricular fibrillation.The patient expired in the cath lab despite the resuscitation attempts.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: 9293100
• Report Number: 2024168-2019-13343
• Device Sequence Number: 2362445
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 11/07/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1012582-26
• Device Lot Number: 8051141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 11/07/2019
• 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: 86 YR
• Patient Weight: 58