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

Catalog Number 1012463-23

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

Patient Problems Angina (1710); Dyskinesia (2363)

Event Date 12/06/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The rx absorb 3.0 x 28 mm referenced is being filed under a separate manufacturer report number.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the u.S.The scaffold remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2016 the patient was admitted with heaviness in chest and 90% stenosis in the ramus and 80% stenosis in the left anterior descending (lad).Vessel sizing was performed using visual estimation which determined the vessel to be greater than 2.5mm in diameter.Predilatation of the ramus was performed with an nc balloon at 18 atmospheres (atm) with residual stenosis less than 40%.A 3.0x23mm absorb was implanted in the vessel which was followed by high pressure post dilation with a 3.0x12 nc balloon at 22 atm.Predilation of the lad was performed with a nc balloon at 16 atm with residual stenosis less than 40%.A 3.0x28mm absorb was implanted followed by high pressure post dilatation with a 3.25x12 nc balloon at 16 atm.The end result was good and timi iii flow was achieved in both of the vessels.Final angiographic residual stenosis was 0% in both of the arteries.No imaging was performed to confirm the absorb scaffolds were fully apposed to the vessel wall.The patient was placed on dual anti-platelet therapy (dapt) consisting of aspirin and clopidogrel.The patient came back with chest pain on (b)(6) 2016 and 80% restenosis was found in the ramus and 90% restenosis was found in the lad.An unspecified drug eluting stent was implanted in each vessel.The procedure was completed without any injury to the patient.The patient was confirmed to have been compliant with their dapt.No additional information was provided.

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.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.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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Subsequent to filing the initial mdr, the following information was received: there was no change to the patient's dual anti-platelet therapy (dapt) post treatment of the restenosis.No additional information was received.

• 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: 6200252
• MDR Text Key: 63185960
• Report Number: 2024168-2016-09162
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2016
• Device Catalogue Number: 1012463-23
• Device Lot Number: 510216A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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: SCAFFOLD: RX ABSORB 3.0 X 28 MM
• Patient Outcome(s): Hospitalization; Required Intervention