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

Catalog Number 1012459-12

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

Patient Problem Stenosis (2263)

Event Date 10/18/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The 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.The reported patient effect of restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) is a known adverse event 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 and there is no indication of a product quality issue with respect to manufacture, design or labeling.The other absorb bvs referenced in describe event or problem and concomitant medical products is filed under a separate medwatch report number.

Event Description

It was reported that on (b)(6) 2013, a 3.0x12mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the mid left anterior descending (lad) coronary artery lesion and a 3.0x12mm scaffold was successfully implanted in the distal right coronary artery (rca) lesion.On (b)(6) 2016, the patient was hospitalized.Two percutaneous procedures were performed, placing an unspecified stent in the 90% restenosed mid lad and the 50% restenosed distal rca.There were no clinical symptoms due to the event.The event resolved without sequela and the patient was discharged from the hospital on (b)(6) 2016.There was no additional information 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: 6100207
• MDR Text Key: 59797576
• Report Number: 2024168-2016-07930
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648157400
• UDI-Public: (01)08717648157400(17)140611(10)30612PB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2014
• Device Catalogue Number: 1012459-12
• Device Lot Number: 30612PB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2013
• 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: ASPIRIN, CLOPIDOGRELSCAFFOLD: ABSORB 3.0 X 12
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 49