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

Catalog Number 1012462-12

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The scaffold remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The two additional absorb devices are filed under separate manufacturer report numbers.

Event Description

It was reported that on (b)(6) 2014, a 2.5x12mm, 3.0x23mm, and a 3.5x28mm absorb bioresorbable vascular scaffold (bvs) were successfully implanted in the proximal circumflex (cx) coronary artery lesion.On (b)(6) 2015, the patient was admitted for a staged, planned procedure to the left anterior descending (lad) coronary artery.Unspecified stents were implanted.On (b)(6) 2016, the patient was admitted to the hospital due to chest tightness, diagnosed as stable angina.A coronary angiogram was performed.The previously implanted lad stents reportedly looked good with mid disease beyond the stented segment in the lad.The cx had stenosis within the scaffold segment.On ivus, the stenosis could not be differentiated between scaffold sites.There was some positive (clinically positive) vessel remodeling in the proximal scaffold segment where the scaffold had expanded.On the contrary however, there was some negative (clinically negative) vessel remodeling in a short scaffold segment, with a loss of radial strength, and low attenuation intimal thickening, with some neo-atherosclerosis associated with potential neo-vessel formation.Per physician, another revascularization was not required and was not performed.There was no additional information provided regarding this issue.

Manufacturer Narrative

(b)(4).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 restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu), are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Subsequent to the previous report submitted, additional information indicates that one of the other absorb bioresorbable vascular scaffolds implanted in the proximal circumflex coronary artery lesion was a 3.0x28mm (not 3.0x23mm as previously reported).

Manufacturer Narrative

(b)(4).

Event Description

Subsequent to the previous medwatch report filed, the additional information was received.On (b)(6) 2016, restenosis was located at the 2.5x12 and 3.0x28 scaffold sites.Prolonged dual antiplatelet therapy (dapt) medications were prescribed due to the event.There was no stenosis in the 3.5x28 scaffold.

• 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: 7245003
• MDR Text Key: 99133220
• Report Number: 2024168-2018-00846
• 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: foreign,health professional,s
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2015
• Device Catalogue Number: 1012462-12
• Device Lot Number: 4031361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• 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
• Treatment: ABSORB BVS (X2)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 88