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); Myocardial Infarction (1969); Thrombosis (2100)
Date of Event	01/17/2017
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.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.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.The reported patient effects of angina, myocardial infarction, 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.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 on (b)(6) 2017, the patient presented with aortic coronary stenosis and underwent a coronary procedure to treat target lesions in the left anterior descending (lad) artery and the right coronary artery (rca).The 3.5 x 28 mm absorb bioresorbable vascular scaffold (bvs) was implanted in the lad and a 2.25 x 15 mm xience alpine was implanted in the rca.On (b)(6) 2017, the patient was re-hospitalized with angina and a st elevation myocardial infarction (stemi) was diagnosed.Angiography noted thrombosis in the 3.5 x 28 mm absorb scaffold.The patient underwent a revascularization procedure, with implantation of a 3.0 x 23 mm xience alpine stent and a 3.0 x 12 mm xience alpine stent inside the absorb scaffold.Post procedure, the patient was in stable condition and the event resolved.Reportedly, the patient was not compliant with brilinta administration, as he reported that he could not afford the prescription.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: 6286896
• Report Number: 2024168-2017-00770
• Device Sequence Number: 13684301
• Product Code: PNY
• UDI-Device Identifier: 08717648213144
• UDI-Public: (01)08717648213144(17)170809(10)6081061
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/30/2017

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: 01/19/2017
• Initial Report FDA Received Date: 01/30/2017
• 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; Disability
• Patient Age: 36 YR
• Patient Weight: 83