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

Catalog Number 1235250-18

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Non specific EKG/ECG Changes (1817); Thrombosis (2100)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 bioresorbable vascular scaffold (bvs) system, absorb gt1, instructions for use (ifu) states: in small vessels (visually assess reference vessel diameter less than or equal to 2.75 mm), on-line qca or intravascular imaging with intravascular ultrasound or optical coherence tomography is strongly recommended to accurately measure and confirm appropriate vessel sizing (reference vessel diameter greater than or equal to 2.5 mm).The reported patient effects of angina and thrombosis, as listed in the ifu, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.It is unknown if the ifu deviation contributed to the reported event.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The 3.0x28 mm absorb gt1 referenced, is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6)2016, two absorb scaffolds, sizes 2.5x18 and 3.0x28, were implanted, using visual assessment, in the mid to distal left anterior descending coronary artery.On (b)(6)2017, the patient presented with chest pain and ekg changes.The two scaffolds were noted to be thrombosed at the site of overlap.A non-abbott stent was implanted as treatment and the condition resolved.There was no reported adverse patient sequela.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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6771137
• MDR Text Key: 81950275
• Report Number: 2024168-2017-06455
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648212963
• UDI-Public: 08717648212963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2017
• Device Catalogue Number: 1235250-18
• Device Lot Number: 6051061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUAL ANTIPLATELET THERAPYABSORB GT1 3.0X28
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR