MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Model Number	1235300-18
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Angina (1710); Stenosis (2263)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for analysis as it was implanted.The investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2017, a percutaneous coronary intervention (pci) was performed on the distal right coronary artery (rca) lesion.Following pre-dilatation, a 3.0x18mm absorb gt1 scaffold (1235300-18, 6100461) was successfully implanted in the distal rca.On (b)(6) 2017, another pci was performed.Following pre-dilatation, a 3.0x23mm absorb scaffold (1235300-23, 6101161) was successfully implanted in the 1st diagonal coronary artery.There were no adverse events and there was no device malfunction.On (b)(6) 2020, the patient was hospitalized for unstable angina.In-scaffold restenosis was observed in the 3.0x18mm absorb gt1 rca scaffold.Another pci with atherectomy and balloon dilatation was performed as treatment.Per physician, the event was not related to a device deficiency.The event resolved.No additional information was provided regarding this issue.
Additional Manufacturer Narrative
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.It should be noted that the reported patient effects of angina and restenosis, as listed in the absorb gt1 instructions for use, are known patient effects that may be associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the subsequent treatment appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture, or labeling of the device.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Common Device Name: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10813960
• Report Number: 2024168-2020-09348
• Device Sequence Number: 11291029
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: 08717648213045
• Combination Product (Y/N): Y
• 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: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 1235300-18
• Device Catalogue Number: 1235300-18
• Device Lot Number: 6100461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/17/2020
• 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: 3.0X23MM ABSORB SCAFFOLD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 62