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); Low Blood Pressure/ Hypotension (1914); Thrombosis (2100); Cardiogenic Shock (2262)
Date of Event	06/21/2017
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.Concomitant product(s): stent: xience alpine 3.25x23 (2), 2.75x23.Dual antiplatelet therapy: plavix and aspirin.The device was not returned for evaluation, as it remains in the patient.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, thrombosis, hypotension and shock, as listed in the absorb gt1 bioresorbable vascular scaffold (bvs) system instructions for use, are known adverse events associated with the use of coronary scaffolds in native coronary arteries.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 the design, manufacture or labeling of the device.The three xience alpine stents referenced, are filed under separate medwatch reports.
Event or Problem Description
It was reported that on (b)(6)2017, the patient underwent a coronary procedure, with implantation of a 3.0 x 18 mm absorb gt1 bioresorbable vascular scaffold (bvs) in the left anterior descending (lad) artery and a 3.25 x 23mm xience alpine stent in the right coronary artery (rca).The patient was prescribed dual anti-platelet therapy (dapt) of aspirin and clopidogrel and was discharged to home.On (b)(6)2017, the patient was re-hospitalized with angina.Coronary angiography was performed and noted thrombosis in both the absorb bvs and in the xience stent.The patient reported being non-compliant with dapt.Thrombectomy was performed.Two additional xience alpine stents were implanted; one in the absorb scaffold in the lad and one in the xience alpine stent in the rca.The clopidogrel was changed to ticagrelor and the patient was discharged to home in stable condition.On (b)(6)2017, the patient was re-hospitalized again, with angina, and thrombosis was noted in both locations (lad and rca).The patient was admitted in cardiogenic shock with blood pressure of 80/59.An intra-aortic balloon pump and a temporary pacemaker were placed and the blood pressure increased to the 150-160 range.The patient reported being non-compliant with dapt.Balloon angioplasty was performed.The patient was in stable condition post procedure.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: 6734926
• Report Number: 2024168-2017-06137
• Device Sequence Number: 16516562
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: 08717648213045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/21/2017

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 Expiration Date: 02/18/2018
• Device Catalogue Number: 1235300-18
• Device Lot Number: 608236A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2017
• Initial Report FDA Received Date: 07/23/2017
• 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: 87 YR