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

Catalog Number	1235350-28
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	02/16/2017
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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina and thrombosis, as listed in the absorb gt1 instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, 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) 2017 was to treat a stenosis in the mid left anterior descending coronary artery.Prior to the initial procedure, the patient's clinical presentation was unstable angina.Pre-dilatation was performed with a 3 x 12 mm balloon.A 3.5 x 28 mm absorb gt1 scaffold was deployed with post-dilatation performed using a 3.5 x 20 non-compliant balloon to 20 atmospheres with the final angiographic residual stenosis less than 10%.It was confirmed that the patient had stopped dapt 10 days after the index procedure.The patient was readmitted on (b)(6) 2017 as he was symptomatic with chest pain when thrombosis was diagnosed.The thrombosis was treated with a xience stent.The patient had a good outcome.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: 6528615
• Report Number: 2024168-2017-03722
• Device Sequence Number: 13218
• Product Code: PNY
• UDI-Device Identifier: 08717648213144
• UDI-Public: (01)08717648213144(17)170809(10)6081061
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P150023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2017

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 Expiration Date: 08/09/2017
• Device Catalogue Number: 1235350-28
• Device Lot Number: 6081061
• 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: 04/27/2017
• 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: 49 YR