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

Catalog Number 1012463-28

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

Patient Problem Prolapse (2475)

Event Date 06/05/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of event has been estimated.Date of implant has been estimated.The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.Literature attachment: lipid plaque modification during resorption of absorb bioresorbable scaffold: insights from optical coherence tomography the additional 3.0x28 absorb referenced 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 through a presentation titled: lipid plaque modification during resorption of absorb bioresorbable scaffold: insights from optical coherence tomography that the procedure was to treat a large obtuse marginal branch artery.The patient presented with non-st segment elevation myocardial infarction.Two 3.0x28mm absorb bioresorbable vascular scaffolds were implanted at the lesion.Post-procedural optical coherence tomography (oct) revealed complete strut apposition, good scaffold expansion and the absence of fracture.The underlying vessel wall showed signs of plaque prolapsing.Oct was performed 4.6 years later, and demonstrated complete scaffold resorption, with good lumen area, suggesting a considerable modification in the overall lipid content.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: date of event has been estimated, date of implant has been estimated.The device remains in the anatomy.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot numbers were not provided.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.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 additional information was received: the index procedure was performed in 2013.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: 8070767
• MDR Text Key: 127139976
• Report Number: 2024168-2018-08795
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1012463-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2018
• 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
• Treatment: STENT: 3.0X28 ABSORB
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 85