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

Model Number 1235300-18

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Stenosis (2263)

Event Date 10/14/2020

Event Type  Injury  

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 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.

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
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10813960
• MDR Text Key: 216659291
• Report Number: 2024168-2020-09348
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: 08717648213045
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.0X23MM ABSORB SCAFFOLD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 62