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

Catalog Number UNK ABSORB

Device Problem Migration (4003)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Angina (1710); Embolism (1829); Ischemia (1942)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

The device remained implanted.Investigation is not yet complete.A follow up report will be submitted with additional information.The absorb device is not commercially available in the u.S.; however, it is similar to a device sold in the us.Literature, titled: migrated remnant bioresorbable scaffolds in a left main bifurcation lesion: insights from optical coherence tomography.

Event Description

An individual case report was obtained from an article titled ¿migrated remnant bioresorbable scaffolds in a left main bifurcation lesion: insights from optical coherence tomography¿.It was reported that on an unspecified date, a 3.5x28mm and 3.0x28mm absorb scaffolds were implanted in the proximal to distal left anterior descending (lad) coronary artery lesion.A 3.0x18mm absorb scaffold was implanted in the distal left circumflex (cx) coronary artery lesion.Three years later, the patient presented with exertional chest pain.Imaging was performed.The lad remained patent, however, severe stenosis was observed in the proximal lcx with vertical filing defect within the left main (lm) coronary artery.Scaffold remnants were observed in the lm bifurcated lesion.As treatment, two xience sierra stents were successfully implanted.Final angiography displayed good distal flow without residual stenosis.No additional information was provided regarding this issue.

Manufacturer Narrative

B3, d6: estimated date.D4: unique device identifier (udi): in the absence of reported part number, udi cannot be calculated.The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided.It should be noted that the reported patient effects of angina, ischemia and embolism, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the reported difficulties and patient effects could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Attachment: literature, titled: migrated remnant bioresorbable scaffolds in a left main bifurcation lesion: insights from optical coherence tomography.Na - attachment: [e-29130 article nms.Pdf].

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE SCAFFOLD
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10185089
• MDR Text Key: 196115333
• Report Number: 2024168-2020-05254
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): Y
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ABSORB
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR