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

Catalog Number	1235300-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Stenosis (2263)
Date of Event	04/03/2018
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.There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.The reported patient effects of ischemia and restenosis, 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.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 on (b)(6) 2017 the 3.0x18 mm absorb gt1 scaffold was implanted in the mid left anterior descending (lad) coronary artery.On (b)(6) 2018 at the one year follow-up visit, coronary angiogram was performed which found asymptomatic ischemia.A de novo lesion was found in the proximal lad, proximal to the mid lad scaffold.On (b)(6) 2018 percutaneous coronary intervention was successfully performed in the lad.Oct (optical coherence tomography) found stenosis in the proximal segment of the mid lad scaffold.The distal lad also had 50% stenosis.Balloon angioplasty was performed with a drug coated balloon dilatation in the stenosis and on the proximal and distal ends of the scaffold.The patient was discharged on (b)(6) 2018.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: 7844494
• Report Number: 2024168-2018-06871
• Device Sequence Number: 11124240
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: 08717648213045
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: 04/01/2018
• Device Catalogue Number: 1235300-18
• Device Lot Number: 6100461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/04/2018
• 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: 67 YR
• Patient Weight: 57