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

Catalog Number 1012463-12

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 03/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The incident information was reviewed; however, 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 effects of angina and stenosis as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse event 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 the design, manufacture, or labeling of the device.

Event Description

It was reported that on (b)(6) 2015 one 3.0x12 mm absorb scaffold was implanted in the distal circumflex (lcx) coronary artery and one 2.5x18 absorb scaffold was implanted in the first obtuse marginal coronary artery.On (b)(6) 2018 the patient underwent a diagnostic coronary angiogram to evaluate the patient's chest pain with tightness on exertion.The angiogram found stenosis in the mid lcx and moderate disease in the ostium of the lcx as well as disease in the non-study vessels, left anterior descending and right coronary artery.The patient is referred for percutaneous or surgical revascularization, but neither of these have been scheduled.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previously filed report, additional information was received that on (b)(6) 2018 the 3.0x12 absorb scaffold was implanted in the mid circumflex coronary artery, not the distal circumflex as was previously thought.The mid circumflex restenosis was within 5 mm of the scaffold, but it was not inside the scaffold itself.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction to year of implant date (2018 to 2015).

Event Description

Subsequent to the previously filed report, it should be noted that the 3.0x12 mm absorb scaffold was implanted on (b)(6) 2015 in the mid circumflex coronary artery.No additional information was provided.

• Brand Name: ABSORB 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: 7527156
• MDR Text Key: 108720626
• Report Number: 2024168-2018-03728
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2018

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: 04/30/2015
• Device Catalogue Number: 1012463-12
• Device Lot Number: 405016A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 06/12/2018; 06/25/2018
• Supplement Dates FDA Received: 06/24/2018; 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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): Other
• Patient Age: 64 YR
• Patient Weight: 101