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

Catalog Number 1012463-18

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

Patient Problems Angina (1710); Myocardial Infarction (1969); Occlusion (1984)

Event Date 12/01/2016

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 relevant information.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.

Event Description

It was reported that on (b)(6) 2016, a coronary angiogram was performed and it revealed triple vessel disease.The patient was advised to undergo percutaneous transluminal coronary angioplasty stent to the left circumflex to the obtuse marginal and balloon angioplasty to the posterior descending coronary artery.A 3.0x18mm bvs scaffold was implanted; however, the patients pain did not subside until (b)(6).On (b)(6) 2016, the patient presented with severe chest pain.A stress echo was performed and resulted positive for reversible myocardial ischemic in three segments (mid distal lateral wall and posterior wall).The stent was completely blocked, not traceable, and blocked the artery from downward to upper side in reverse direction.As advised by the doctors, there was no other alternative except to go for by-pass surgery.Cardiac artery bypass graft was performed on (b)(6) 2017.No additional information was provided.

Manufacturer Narrative

(b)(4).A cine from procedure on (b)(6) 2016 was received and reviewed by an abbott vascular clinical specialist.The reviewer stated: per cine review there is no contrast flow beyond the proximal left circumflex (lcx).From the images provided, the lcx appears to be totally occluded well proximal to the scaffold implant site.

Manufacturer Narrative

(b)(4).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, myocardial infarction and occlusion, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use 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 initially filed report, the following additional information was received: during the initial procedure, the lesion was pre-dilated with a 2.75x10mm balloon at 14 atmospheres (atm) and the absorb bvs scaffold was post-dilated with a 3.0x10mm balloon at 14 atm.The final angiographic residual stenosis was 0%.The patient was prescribed aspirin and brilinta following the initial procedure as part of the dual antiplatelet drug therapy (dapt); however, it could not be confirmed if the patient was compliant with the dapt.Following the cardiac artery bypass graft surgery performed on (b)(6) 2017, the patient was discharged home in stable condition.No additional information was provided.

Manufacturer Narrative

(b)(4).Further review and assessment of the cine, by abbott vascular director medical affairs states: this is a case of complex multi vessel percutaneous coronary intervention.The absorb bvs scaffold was implanted in the left circumflex (lcx) and was post dilated.In the angiograms at the completion of the procedure there is haziness in the vessel proximal to the scaffold.This haziness may represent unintended injury to the vessel during the procedure or may be disease that was left untreated.In the follow-up angiogram, the hazy area seen 1 year before now has totally occluded proximal to the proximal markers of the scaffold.There does not appear to be a product issue in this case.Late occlusion is seen in the lcx and is located remote from the scaffold in the proximal vessel.

• 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: 7481924
• MDR Text Key: 107186354
• Report Number: 2024168-2018-03247
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/26/2018

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: 03/01/2017
• Device Catalogue Number: 1012463-18
• Device Lot Number: 603026A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 06/13/2018; 06/13/2018; 07/24/2018
• Supplement Dates FDA Received: 06/13/2018; 06/13/2018; 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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: 60 YR
• Patient Weight: 65