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 Problem Death (1802)

Event Date 07/18/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that on (b)(6) 2014, the patient underwent a coronary procedure with implantation of two absorb bioresorbable vascular scaffolds (bvs) in the proximal and mid right coronary artery (rca).On (b)(6) 2016, approximately 2 years later, the patient was found dead at home.Cause of death is unknown.No additional information provided.

Manufacturer Narrative

(b)(4).Although the patient death, due to ischemic heart disease and right coronary artery atheroma, is not related to the implanted absorb scaffolds or procedure; it was previously reported.Because the initial report has already been filed, this event must remain reportable.No investigation required.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

Event Description

Subsequent to the initial 30-day medwatch report, additional information was received.On (b)(6) 2016, the patient was found dead at home.Paramedics performed cardiopulmonary resuscitation (cpr); however, the patient could not be revived.Cause of death was listed at ischemic heart disease and right coronary artery atheroma.Secondary cause of death was listed as diabetes mellitus type 2 and chronic obstructive pulmonary disease.The study physician has deemed this event as unrelated to the study devices or study procedure.Although the patient death, due to ischemic heart disease and right coronary artery atheroma, is not related to the implanted absorb scaffolds or procedure, this event has been reported; therefore, it will remain reportable.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: 6839217
• MDR Text Key: 84449231
• Report Number: 2024168-2017-07250
• 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
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2014
• Device Catalogue Number: 1012463-18
• Device Lot Number: 3073161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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 3.0X28 ASPIRIN, CLOPIDOGREL
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 66