MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB; BIORESORBABLE SCAFFOLD

Model Number	1235250-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There was no reported device malfunction and the product was not returned.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 effect of stenosis, as listed in the absorb gt1 instructions for use (ifu), is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
Patient id (b)(6).It was reported that on (b)(6) 2017, the patient underwent a coronary procedure performed to treat a lesion in the distal circumflex artery.A 2.5 x 18 mm absorb gt1 bioresorbable vascular scaffold (bvs) was implanted.On (b)(6) 2020, a new area of stenosis, within 5 mm from the previously implanted absorb scaffold, was noted.On (b)(6) 2020, the patient was re-hospitalized and a revascularization procedure was performed, resolving the event.No additional information was provided.

• Brand Name: ABSORB
• Common Device Name: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9875793
• Report Number: 2024168-2020-02828
• Device Sequence Number: 2910685
• Product Code: PNY
• UDI-Device Identifier: 08717648212963
• UDI-Public: 08717648212963
• 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
• Type of Report: Initial
• Report Date (Section B): 03/24/2020

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 Model Number: 1235250-18
• Device Catalogue Number: 1235250-18
• Device Lot Number: 6100461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/24/2020
• 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: 52 YR
• Patient Weight: 69