MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number	1235300-18
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	03/15/2017
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.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot numbers were not provided.The reported patient effects of angina and thrombosis, as listed in the absorb gt1 instructions for use (ifu) are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure on (b)(6) 2016 was to treat a stenosis in the posterior descending coronary artery.Prior to the initial procedure, the patient's clinical presentation was unstable angina.For the index procedure, it is unknown how the lesion was prepped however after implantation of the absorb gt1 3.0 x 18 mm scaffold, post-dilatation was performed with an nc trek 3 x 12 mm balloon dilatation catheter with final angiographic residual stenosis less than 10%.The patient was readmitted on (b)(6) 2017 presenting with chest pain when thrombosis was diagnosed.The thrombosis was treated with a 2.25 x 14 non-abbott stent.The patient outcome was good.It is unknown if patient was compliant with dual anti platelet therapy (dapt) after the initial procedure or if there have been any changes to the patient's medications following the diagnosis of thrombus.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6513740
• Report Number: 2024168-2017-03504
• Device Sequence Number: 13817486
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: (01)08717648213045
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2017

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 Catalogue Number: 1235300-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2017
• Initial Report FDA Received Date: 04/22/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 52 YR