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

Catalog Number 1235350-18

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

Patient Problems Myocardial Infarction (1969); Thrombosis (2100)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the initial procedure on (b)(6) 2016 was to treat a lesion located in the mid-proximal left anterior descending coronary artery.Pre-dilatation was performed, reducing the stenosis to less than 40%, prior to implanting the absorb gt1 3.5 x 18 mm scaffold.It was confirmed that the patient had been compliant in following the dual anti platelet drug therapy after the procedure.On (b)(6) 2016, the patient returned with an st segment elevation myocardial infarction (stemi) and scaffold thrombosis was discovered.After aspiration of the thrombosis, balloon angioplasty was performed and a xience alpine 4.0 x 28 mm stent was implanted.Post-dilatation was performed with a non-compliant non-abbott 4.0 x 20 mm balloon and the final patient outcome was good.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A cine was received and reviewed by an abbott vascular physician.The reviewer concluded that the sub-acute thrombosis of the absorb scaffold in the proximal lad was most likely due to untreated (unrecognized) proximal edge dissection that seems to have resulted in a compressive intra-mural hematoma or intra-scaffold thrombosis based on review of all angiograms and the intravascular ultrasound at the time of the occlusion.Thus, the event seems to have been the result of a procedural mechanical complication.The reported patient effects of dissection, myocardial infarction and thrombosis, as listed in the absorb gt1 instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

A review of the cine by an abbott vascular physician noted a dissection at the proximal edge of the absorb gt1 scaffold.

• 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: 6124681
• MDR Text Key: 60789753
• Report Number: 2024168-2016-08299
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213120
• UDI-Public: (01)08717648213120(17)170718(10)6071961
• 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,Followup
• Report Date: 01/13/2017

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: 07/18/2017
• Device Catalogue Number: 1235350-18
• Device Lot Number: 6071961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 118