MAUDE Adverse Event Report: AV-TEMECULA-CT GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

Catalog Number	1012582-26
Health Effect - Clinical Codes	Death (1802); No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 did not indicate a lot specific quality issue.The investigation determined the reported device operates differently than expected (failure to seal the perforation) appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other two graftmaster devices (3.5 x 16, and 4.0 x 19 mm) are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that this was a procedure to treat the patient with an acute, ongoing myocardial infarction whose health was declining prior to use of the graftmaster stent.Three graftmasters, (sizes 3.5 x 16, 4.0 x 19, and 4.0 x 26 mm) were implanted to treat the coronary perforation in the right coronary artery (rca), but these were not large enough to seal the perforation.The perforation was discovered to be larger than initially anticipated/ visualized angiographically, but a larger graftmaster size was not available.The perforation was unable to be sealed.The patient expired from suspected cardiac tamponade.In the opinion of the physician, use of the graftmasters did not cause or contribute to the patient death.No additional information was provided.

• Brand Name: GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
• Common Device Name: CORONARY STENT GRAFT
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7429684
• Report Number: 2024168-2018-02764
• Device Sequence Number: 16657369
• Product Code: MAF
• UDI-Device Identifier: 08717648176463
• UDI-Public: 08717648176463
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: H000001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: 04/30/2018
• Device Catalogue Number: 1012582-26
• Device Lot Number: 6051141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: GRAFTMASTER (3.5X16, 4.0X19)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Weight: 77