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

Catalog Number	1235300-12
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802)
Date of Event	12/23/2016
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.Product performance engineering reviewed the incident information; however, there was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.The reported patient effects of cardiac arrest, death and thrombosis, as listed in the instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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) 2016 was to treat an 80% stenosis in the proximal to mid left anterior descending (lad) artery with no tortuosity and no calcification.The patient presented with non- st elevated myocardial infarction (nstemi).Vessel sizing was evaluated using an optical coherence tomography (oct) and was determined to be greater than 2.5 mm.A 3.0 x 8 mm nc trek balloon was used for pre-dilatation, reducing the stenosis to 40%.A 3.0 x 12 mm absorb gt1 bioresorbable vascular scaffold (bvs) was implanted.Post-dilatation was performed with a 3.0 x 12 mm trek with the final angiographic residual stenosis less than 10%.Oct confirmed that the scaffold was fully opposed to the vessel wall.It was reported that patient visited a va hospital on an unknown date between (b)(6) 2016 and the physician requested the patient to be taken off of all previously prescribed blood thinning medications due to chronic nose bleeds.On (b)(6) 2016, the patient was re-admitted with cardiac arrest and thrombosis was found.The thrombosis was aspirated and balloon angioplasty was performed, achieving a timi 3 flow.On (b)(6) 2016, the patient was re-admitted in the hospital with full cardiac arrest and advanced cardiac life support protocol was performed.Angiography was done and confirmed that the scaffold in the lad was patent, without diminished blood flow.This time the patient remained hospitalized.On (b)(6) 2017, the patient expired in the hospital.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: 6312865
• Report Number: 2024168-2017-01053
• Device Sequence Number: 19234915
• Product Code: PNY
• UDI-Device Identifier: 08717648213021
• UDI-Public: (01)08717648213021(17)160401(10)6051661
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/08/2017

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: 04/01/2016
• Device Catalogue Number: 1235300-12
• Device Lot Number: 6051661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2017
• Initial Report FDA Received Date: 02/08/2017
• 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: Death
• Patient Age: 70 YR
• Patient Weight: 90