MAUDE Adverse Event Report: ABBOTT VASCULAR INC. GRAFTMASTER; CORONARY COVERED STENT

Model Number	1012580-19
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Cardiac Tamponade (2226); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
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.
Event or Problem Description
It was reported that during a the use of a 2.8x19mm graftmaster covered stent it was noted to cause or contribute to the perforation and cardiac tamponade.Treatment is unknown, however, perforation was noted to be sealed and no clinically significant delay in the procedure was reported.No additional information was provided.
Event or Problem Description
Subsequently, after the report was filed it was noted that graftmaster covered stent did not cause or contribute to the perforation nor cardiac tamponade.He perforation was noted on the echogram and unspecified balloons were used in an attempt to seal the perforation; however, were unsuccessful.Cardiac tamponade was noted.An unspecified regular stent (not covered stent) was implanted in an attempt to seal the perforation was attempted, but also failed to seal.Therefore, the graftmaster was advanced and deployed without issue.Imagining showed graftmaster sealed the perforation.Once the perforation was sealed, pericardiocentesis was performed to remove the blood.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.A review of the production record for the reported lot was performed and revealed no manufacturing nonconformities.The investigation was unable to determine any issue with the device as no patient effects or device malfunction/failure mode was reported.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6 correction: health effect - clinical codes 2135, 2226 removed; code 4582 added.H6 correction: health effect - impact code 4614 was removed; code 2199 added.H6 correction: medical device problem code 2993 removed; code 3189 added.

• Brand Name: GRAFTMASTER
• Common Device Name: CORONARY COVERED STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 21256550
• Report Number: 2024168-2025-00967
• Device Sequence Number: 13009094
• Product Code: NIV
• UDI-Device Identifier: 08717648176357
• UDI-Public: (01)08717648176357(17)250930(10)3102541
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/19/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 1012580-19
• Device Catalogue Number: 1012580-19
• Device Lot Number: 3102541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Race: White