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

Model Number	1012581-26
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 graftmaster was used past the expiration date.A review of the graftmaster label attached to the lot history record for this lot was conducted indicating a manufacturing date of (b)(6) 2018 with an expiration date (use by date) of (b)(6) 2019.The product was used after expiration as it was reported the procedure occurred on (b)(6) 2020.The expiration date of the product is important for sterility, efficacy, and performance of the device.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, states: note the product use by date specified on the package.The investigation determined the reported device expiration issue appears to be related to the use error.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 a 3.5x26mm graftmaster covered stent was used to treat a free perforation that occurred in the mid left anterior descending coronary artery on (b)(6) 2020.The stent successfully covered the perforation; however, the stent was used after the expiration date of (b)(6) 2019.As per the physician, the graftmaster did not cause or contribute to additional complications or adverse events.There were no adverse patient effects and no clinically significant delay in the procedure.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: 9828965
• Report Number: 2024168-2020-02397
• Device Sequence Number: 741036
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 8011741
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR