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

Catalog Number	1235250-18
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	01/03/2017
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.Date of implant - estimated.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 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 and 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 in (b)(6) 2016, a 2.5x18mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted with post-dilatation, in the posterior descending artery (pda).The patient was discharged with a prescription for brilinta, but did not fill the prescription.Reportedly, the patient had plavix at home, so they took the plavix instead of the brilinta.At the end of (b)(6) 2016, the patient ran out of plavix and was not on dual antiplatelet therapy (dapt) for about one week prior to (b)(6) 2017, when the patient reported having chest pain.On (b)(6) 2017, angiography was performed and thrombus was noted in the bvs.The bvs was noted to be well apposed to the vessel wall.Ballooning was performed and 3 xience alpine stents were implanted, resolving the event.There was no additional information 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: 6258898
• Report Number: 2024168-2017-00540
• Device Sequence Number: 955493
• Product Code: PNY
• UDI-Device Identifier: 08717648212963
• UDI-Public: (01)08717648212963
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/17/2017

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: 1235250-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 01/17/2017
• 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: 60 YR