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

Catalog Number 1235300-18

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

Patient Problem Stenosis (2263)

Event Date 02/19/2019

Event Type  Injury  

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.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 restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, 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 design, manufacture or labeling of the device.

Event Description

It was reported that on (b)(6) 2017, the patient underwent a coronary stenting procedure, with implantation of a 3.0 x 18 mm absorb gt1 scaffold in the mid left anterior descending (lad) artery.On (b)(6) 2019, coronary angiography was performed during a follow up visit.90% stenosis was noted within the implanted scaffold area.No additional intervention was performed; however, percutaneous coronary intervention procedure is scheduled for (b)(6) 2019, with planned stent implantation.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Additional information: event description, relevant tests, and evaluation codes.

Event Description

Subsequent to the initial 30-day medwatch report, the following information was provided: the patient was re-hospitalized on (b)(6) 2019.Revascularization was performed on (b)(6) 2019 and a 2.75 x 26 mm drug eluting stent was implanted to treat in-stent restenosis.The patient condition resolved on (b)(6) 2019 and the patient was discharged.No additional information was provided.

• Brand Name: ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8458671
• MDR Text Key: 140118533
• Report Number: 2024168-2019-02380
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213045
• UDI-Public: 08717648213045
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 1235300-18
• Device Lot Number: 6100461
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 56