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

Catalog Number	1235300-28
Health Effect - Clinical Codes	Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis (2100)
Date of Event	07/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 bioresorbable vascular scaffold (bvs) system, instructions for use, are known adverse events associated with the use of a coronary scaffold 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 absorb gt1 2.5x18 referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that on (b)(6) 2016, two absorb scaffolds, sizes 2.5x18 and 3.0x28, were implanted, using visual assessment, in the mid to distal left anterior descending coronary artery.On (b)(6) 2017, the patient presented with chest pain and ekg changes.The two scaffolds were noted to be thrombosed at the site of overlap.A non-abbott stent was implanted as treatment and the condition resolved.There was no reported adverse patient sequela.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: 6771141
• Report Number: 2024168-2017-06456
• Device Sequence Number: 881565
• Product Code: PNY
• UDI-Device Identifier: 08717648213069
• UDI-Public: 08717648213069
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 08/07/2017

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: 05/08/2017
• Device Catalogue Number: 1235300-28
• Device Lot Number: 6050961
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DUAL ANTIPLATELET THERAPYABSORB GT1 2.5X18
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 52 YR