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

Catalog Number 1234350-18

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

Patient Problems Angina (1710); Stenosis (2263); Test Result (2695)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.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 effects of angina and stenosis are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use as known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 manufacture, design or labeling.The additional absorb gt1 referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was to treat a left anterior descending (lad) artery.Two absorb gt1 were implanted on (b)(6) 2016; a 3x12mm absorb gt1 in the mid lad and a 3.5x18mm absorb gt1 in the proximal-mid lad.Patient was compliant to dual antiplatelet therapy treatment.On (b)(6) 2020, patient was symptomatic with chest pain and slight positive stress test.Optical coherence imaging was performed and it was noted that there was restenosis at the two absorb stents.Pre-dilatation was performed with a 3x15mm and 3.5x12mm trek balloons.Then three xience sierra stents (3.5x12, 4.0x15, 2.5x18) were implanted at the lesion.Standard post-dilatation was further performed with a 4x15mm nc trek and a 1.2x12mm mini trek balloons.There were no issues with the xience stents as they were apposed well.The final result was good.There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10356069
• MDR Text Key: 201369234
• Report Number: 2024168-2020-06409
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2016
• Device Catalogue Number: 1234350-18
• Device Lot Number: 5072861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3X12MM ABSORB GT1
• Patient Outcome(s): Hospitalization; Required Intervention