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

Model Number 1012581-16

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2020

Event Type  malfunction  

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.It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, domestic instructions for use, (ifu) 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.The 2.8 x 19 mm graftmaster stent system is filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a lesion in the distal left anterior descending (lad) artery.During use of an unspecified device, a perforation occurred.The 2.8 x 19 mm graftmaster stent delivery system was advanced; however, resistance was noted and the delivery system shaft broke.Blood was noted on pull-back.The device was removed without resistance.A second graftmaster, a 3.5 x 16 mm, was then used; however, this stent was expired, but since it was the only one available, it was used.The stent was implanted without issue and the perforation was sealed.Post procedure, the patient was in stable condition.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Type of Device: CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10371338
• MDR Text Key: 201878382
• Report Number: 2024168-2020-06561
• Device Sequence Number: 1
• Product Code: MAF
• UDI-Device Identifier: 08717648176395
• UDI-Public: 08717648176395
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H000001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 1012581-16
• Device Catalogue Number: 1012581-16
• Device Lot Number: 7111641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 44