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

Catalog Number 1012462-18

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

Patient Problem Aneurysm (1708)

Event Date 09/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the us.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the lot numbers were not provided.The reported patient effect of aneurysm, 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 information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.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.

Event Description

It was reported that the procedure on (b)(6) 2013 was to treat a lesion in the proximal circumflex.Pre-dilatation was done with 2.0x12mm and 2.5x12mm balloons.A 2.5x18mm absorb scaffold was implanted and post-dilated with a 3.0x8mm non-compliant balloon at 18 atmospheres.The patient returned on (b)(6) 2016, aysmptomatic, to check progress in the left anterior descending artery.Optical coherence tomography (oct) control angio was done and an aneurysm was observed at the site of the scaffold.There was no treatment performed.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: 6110512
• MDR Text Key: 60258765
• Report Number: 2024168-2016-08042
• Device Sequence Number: 1
• Product Code: PNY
• UDI-Device Identifier: 08717648156946
• UDI-Public: (01)08717648156946
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012462-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other