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

Catalog Number 1012464-12

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

Patient Problems Angina (1710); Stenosis (2263); Test Result (2695)

Event Date 05/23/2017

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 additional relevant information.The 3.5 x 28 absorb bioresorbable vascular scaffold (bvs) referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.

Event Description

It was reported that on (b)(6) 2015, a 3.5 x 28 mm and a 3.5 x 12 mm absorb bioresorbable vascular scaffolds (bvs) were successfully implanted in the mid right coronary artery (rca) lesion.On (b)(6) 2017, the patient was hospitalized for unstable angina and a positive stress test.Coronary imaging was performed and diffuse mid rca restenosis was noted.Another percutaneous intervention was performed, placing an unspecified drug eluting stent (des) in the mid rca as treatment.The event resolved on (b)(6) 2017.There was no additional information provided.

Manufacturer Narrative

(b)(4).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.It should be noted that the reported patient effects of angina and restenosis, as listed in the absorb bioresorbable scaffold system instructions for use (ifu), are known adverse events 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; however, the reported treatments appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

Subsequent to the previously filed medwatch report, additional information was received: on (b)(6) 2017, the patient complained of dyspnea on exertion and chest heaviness.Restenosis was noted in both the 3.5x28mm and a 3.5x12mm absorb bioresorbable vascular scaffolds and another stent was implanted as treatment.On (b)(6) 2017, the patient was discharged home.

• 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: 6647060
• MDR Text Key: 77760351
• Report Number: 2024168-2017-05143
• 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
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2015
• Device Catalogue Number: 1012464-12
• Device Lot Number: 4111261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 3.5X28MM ABSORB BIORESORBABLE VASCULAR SCAFFOLD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 66