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

Model Number	1012581-26
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents.The reported patient effect of death 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.Per the physician, the cause of death was due to pulseless electrical activity, unrelated to the graftmaster stent.The investigation was unable to determine a conclusive cause for the reported failure to advance.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The xience sierra stent system and the other graftmaster referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that during a left anterior descending coronary artery intervention, a 3.5 x 23mm xience sierra stent was advanced but failed to reach the lesion.Angiography showed a significant perforation.Patient became hypotensive and went into cardiac arrest.Cardiopulmonary resuscitation was performed, and a temporary pacemaker was placed, successfully reviving the patient.A 3.5x26mm graftmaster stent system was advanced but failed to reach the perforation and was removed without issue.Two additional graftmaster stents (3.5x19mm, 3.5x16mm) were advanced and successfully sealed the perforation; however, a distal edge dissection was noted.A 3x12mm xience sierra stent was implanted to successfully treat the dissection.Additionally, during this procedure, it was noted that the patient had severe aortic stenosis and was placed on an intra-arterial balloon pump.Aortic balloon valvoplasty was performed, with good results.Post procedure, the patient remained in critical condition with a poor prognosis.Later that evening, the patient died from pulseless electrical activity.There was no additional information provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10451761
• Report Number: 2024168-2020-07098
• Device Sequence Number: 4044028
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 08/25/2020

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: 08/31/2021
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 9093041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/25/2020
• 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: 84 YR
• Patient Weight: 73