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

Catalog Number 1235300-23

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

Patient Problems Angina (1710); Thrombosis (2100)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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.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 and treatment appears to be related to the circumstances of the procedure.The reported patient effects of angina 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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The additional absorb gt1 referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2016 one 3.0x28 and one 3.0x23 absorb gt1 scaffold were implanted in the heavily calcified, mid to distal left anterior descending coronary artery.The patient had chest pain on (b)(6) 2016 and was found to have in-scaffold thrombosis in both scaffolds.The thrombus was treated with balloon dilatation using a non-compliant balloon.The patient had a good outcome.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: 6100334
• MDR Text Key: 59818654
• Report Number: 2024168-2016-07934
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648213052
• UDI-Public: (01)08717648213052(17)170512(10)6051361
• 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: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2017
• Device Catalogue Number: 1235300-23
• Device Lot Number: 6051361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• 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: OTHER: 3.0X28 ABSORB GT1 SCAFFOLD
• Patient Outcome(s): Hospitalization; Required Intervention