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

Catalog Number	1012583-16
Health Effect - Clinical Code	Death (1802)
Date of Event	05/17/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(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.The investigation was unable to determine a conclusive cause for the reported failure to seal the perforation.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.In addition, the reported patient effect of death is listed in the graftmaster rapid exchange (rx) coronary stent graft system, domestic instructions for use (ifu), as a known patient effect of coronary stenting procedures.It was reported that the graftmaster was deployed with a maximum pressure of 14 atmospheres (atm).It should be noted in the graftmaster rapid exchange (rx), coronary stent graft system, domestic, instructions for use (ifu) specifies: deploy the stent graft slowly by pressurizing the delivery system in 2-atm increments, every 5 seconds, until the stent graft is completely expanded.Fully expand the stent graft by inflating to nominal pressure at a minimum.The ifu, table 10 specifies the nominal pressure is 15 atmospheres (atm).It is unknown if the ifu deviation contributed to the reported event.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other graftmaster devices referenced in describe event or problem is being filed under a separate medwatch report.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the proximal mid left anterior descending (lad) artery.The patient presented with heart failure and non-st-elevation myocardial infarction (nstemi), and was deemed not to be a surgical candidate.The perforation could not be sealed after five graftmaster stents were deployed at maximum pressure (14 atmospheres).A 4.5 x 16 mm and a 3.5 x 16 mm graftmaster stent were implanted to seal the perforation, but the stents could not seal the large perforation, and therefore another 3.5 x 16 mm and a 2.5 x 16 mm graftmaster stents were implanted inside the first two stents to help seal the perforation.A decision was made to implant a final stent, a 2.5 x 16 graftmaster stent to ensure the target lesion was fully covered.However, the patient's vessels were so fragile that the proximal and mid lad split open after rotational atherectomy.The physician reported that the perforation was too large and the patient expired as a result of the rotational atherectomy, and not the graftermaster stents.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: 7591387
• Report Number: 2024168-2018-04385
• Device Sequence Number: 14008725
• Product Code: MAF
• UDI-Device Identifier: 08717648176470
• UDI-Public: 08717648176470
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/12/2018

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: 08/31/2018
• Device Catalogue Number: 1012583-16
• Device Lot Number: 6090141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Weight: 102