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

Catalog Number	1012580-16
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Difficult to Advance (2920); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Ventricular Fibrillation (2130); Pericardial Effusion (3271); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional graftmaster rx devices referenced in b5 are filed under separate medwatch report numbers.H6: device code 2017- improper or incorrect procedure or method- re-insertion.
Event or Problem Description
It was reported that the procedure was to treat the proximal circumflex and mid left anterior descending (lad) coronary arteries.The area was dilated with a non-abbott 2.0x20 mm balloon and 2 non abbott stent delivery systems (sds) were attempted to be advanced but did not cross.Further pre-dilatation was performed and again a non-abbott sds failed to cross.A mini trek balloon was advanced and inflated and a fourth non-abbott sds failed to cross the lesion.More pre-dilatation was performed and rotablation was performed.A non-abbott stent was implanted and post dilated.The 2.8x16 mm graftmaster covered stent was attempted to be advanced but failed to cross so more pre-dilatation was performed.The 2.8x16 mm graftmaster was advanced again and implanted at 14/15 atmospheres but did not seal the perforation.Another 2.8x16 mm graftmaster was advanced and implanted at 15 atmospheres but did not seal the perforation.Pericardiocentesis was performed and the patient was intubated.A 5fr pigtail catheter was inserted into the pericardial space and a non-abbott balloon was advanced and inflated to 15 atmospheres for 20 minutes.The 3.5x16 mm graftmaster covered stent was then advanced and did not cross so it was removed.Further pre-dilatation was performed and ventricular fibrillation was noted so the patient was shocked at 150 joules.A non-abbott stent was advanced and deployed and then the 3.5x16 mm graftmaster was advanced again and deployed at 15 atmospheres but did not seal the perforation.The patient was sent for emergent coronary artery bypass graft (cabg) surgery.Later the patient expired in the intensive care unit.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat the proximal circumflex and mid left anterior descending (lad) coronary arteries.The area was dilated with a non-abbott 2.0x20 mm balloon and 2 non abbott stent delivery systems (sds) were attempted to be advanced but did not cross.Further pre-dilatation was performed and again a non-abbott sds failed to cross.A mini trek balloon was advanced and inflated and a fourth non-abbott sds failed to cross the lesion.More pre-dilatation was performed and rotablation was performed.A non-abbott stent was implanted and post dilated.The 2.8x16 mm graftmaster covered stent was attempted to be advanced but failed to cross so more pre-dilatation was performed.The 2.8x16 mm graftmaster was advanced again and implanted at 14/15 atmospheres but did not seal the perforation.Another 2.8x16 mm graftmaster was advanced and implanted at 15 atmospheres but did not seal the perforation.Pericardiocentesis was performed and the patient was intubated.A 5fr pigtail catheter was inserted into the pericardial space and a non-abbott balloon was advanced and inflated to 15 atmospheres for 20 minutes.The 3.5x16 mm graftmaster covered stent was then advanced and did not cross so it was removed.Further pre-dilatation was performed and ventricular fibrillation was noted so the patient was shocked at 150 joules.A non-abbott stent was advanced and deployed and then the 3.5x16 mm graftmaster was advanced again and deployed at 15 atmospheres but did not seal the perforation.The patient was sent for emergent coronary artery bypass graft (cabg) surgery.Later the patient expired in the intensive care unit.Subsequent to the initially filed reports it was reported that the lesion was a heavily calcified circumflex coronary lesion.After rotablation and deployment of a 3.0x22 mm drug eluting stent which had a waist, post-dilatation was performed until the waist was gone.This is when the perforation was noted.The first 2.8x16 mm graftmaster covered stent did not initially fail to cross the lesion, it was able to advance through existing stents that were deployed before it was used.Both 2.8x16 mm graftmaster devices were implanted without issue but due to poor visualization and the inability to move to another location to visualize the precise tear location and the size of the perforation, the bleeding was unable to be stopped.Balloon tamponade was performed.The third graftmaster covered stent was inserted but could not cross stents which were already in the anatomy.Therefore, a 2.5x22 drug eluting stent was placed distal to the first 2.8x16 mm graftmaster stent.Per the physician, the use of the graftmaster devices did not cause or contribute to the patient death.The patient health was declining toward death before the use of any graftmaster stent.Additionally, the correct sizes for the perforation were not available.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.A review of the complaint handling database was not performed because the failure mode was not specified.Based on the additional information received from the site stating the device did not fail to seal and there were no adverse patient effects due to this device, this would not be a reportable complaint.Therefore, no investigation was performed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 correction: health effect - clinical codes 3271 and 2130 removed; 4582 added.Health effect - impact code 4641 removed; 2199 added.Medical device problem codes 2682, 2920, and 2017 removed; 3189 added.

• 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: 19281275
• Report Number: 2024168-2024-05708
• Device Sequence Number: 7669169
• Product Code: MAF
• UDI-Device Identifier: 08717648176340
• UDI-Public: (01)08717648176340(17)240430(10)2053141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 06/13/2024

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: 04/30/2024
• Device Catalogue Number: 1012580-16
• Device Lot Number: 2053141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2024
• Supplement Date Received by Manufacturer: 05/21/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/31/2022
• 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: PROWATER GUIDE WIRE; RESOLUTE ONYX 2.5X18, 3.0X22 STENTS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: Asian