MAUDE Adverse Event Report: ABBOTT VASCULAR ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE SCAFFOLD

Catalog Number UNK ABSORB

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Age - average, date of event ¿ estimated, treatment/therapy start date - estimated, the unique device identifier (udi) is unknown because the part number and lot number were not provided.Date of implant ¿ estimated.The devices remain implanted and are not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other devices and events are filed under separate medwatch report numbers.Attached article titled, "everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of st-segment elevation myocardial infarction: a randomized controlled trial".

Event Description

It was reported in a research article that compared the performance of absorb scaffolds and xience stents.The following may be related to each implanted device: mal-apposed struts, stent recoil, late lumen loss (obstruction/occlusion), and stenosis.The article is titled: "everolimus-eluting bioresorbable scaffold versus everolimus-eluting metallic stent in primary percutaneous coronary intervention of st-segment elevation myocardial infarction: a randomized controlled trial".Please see the attached article for more details.

Manufacturer Narrative

The devices remain implanted and were not returned for analysis.A review of the electronic lot history records (elhr) and lot level similar incident reviews for this product were not performed because the part and lot numbers were not reported and the products were not returned for analysis.The investigation determined a conclusive cause for the reported patient-device incompatibilities (wall appositions and recoils) cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16134949
• MDR Text Key: 308612258
• Report Number: 2024168-2023-00376
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• Reporter Country Code: NO
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• 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 Age: 61 YR
• Patient Sex: Male