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

Model Number	1012581-26
Medical Device Problem Codes	Off-Label Use (1494); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a chronic occlusion in the mid right coronary artery.The 3.50x26mm graftmaster rx failed to cross the lesion.Therefore, the occlusion was treated with balloon angioplasty.There was no adverse patient effect reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The 2.75x33mm xience sierra stent referenced in b5 is being filed under a separate medwatch report number.B1: updated to product problem.B5: additional information.D9: updated from asku to no.H1: updated to malfunction.H6: 1494 was updated from 1494/incorrect anatomy to 1494/indication for use.
Event or Problem Description
It was reported that the procedure was to treat a chronic occlusion in the mid right coronary artery.The 3.50x26mm graftmaster rx failed to cross the lesion.Therefore, the occlusion was treated with balloon angioplasty.There was no adverse patient effect reported and no clinically significant delay reported.Subsequently, after the initial was filed it was noted the patient presented for an atherectomy procedure using a non-abbott device followed by placement of four overlapping xience sierra stents (2.75x33, 2.75x15, 3.0x38 and 3.5x33mm).All were inflated to 18 atmospheres for 20 seconds.An edge dissection was noted and the graftmaster was attempted to treat the dissection; however, failed to cross due to anatomy.The dissection was treated with balloon angioplasty.No additional information was provided.
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 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: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2.75 mm in diameter.In this case, it is unknown if the ifu deviation directly caused or contributed to the reported event.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• 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: 13795628
• Report Number: 2024168-2022-02772
• Device Sequence Number: 5032759
• Product Code: MAF
• UDI-Device Identifier: 08717648176418
• UDI-Public: 08717648176418
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2022

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: 03/31/2023
• Device Model Number: 1012581-26
• Device Catalogue Number: 1012581-26
• Device Lot Number: 1042941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 03/23/2022; 04/18/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/14/2022; 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.75X15MM XIENCE SIERRA.; 2.75X33MM XIENCE SIERRA.; 3.0X38MM XIENCE SIERRA.; 3.5X33MM XIENCE SIERRA.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 91 KG