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

Device Problem Product Quality Problem (1506)

Patient Problems Angina (1710); Occlusion (1984); Thrombosis (2100); Tissue Damage (2104); Stenosis (2263)

Event Date 03/23/2019

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, implant date, therapy date: estimated dates.The scaffolds remain in the patients.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The absorb device is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.Article titled: "oct-assessment of scaffold resorption: analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds.".

Event Description

This case was captured based on a literature review.It was reported through a research article that absorb bioresorbable vascular scaffold stents may not reabsorb as quickly as initially assumed and may be related to thrombosis, restenosis, target lesion failure [occlusion], progression of coronary artery disease, peri-strut low intensity areas and stable angina.It was also reported that additional percutaneous coronary intervention may be required to treat in-stent restenosis of these stents.Specific patient information is documented as unknown.Details are listed in the article "oct-assessment of scaffold resorption: analysis of strut intensity by a new resorption index for poly-l-lactic acid bioresorbable vascular scaffolds.".

Manufacturer Narrative

Internal file number - (b)(4).The unique device identifier (udi) is unknown because the part and lot numbers were not provided.Correction: mfr site: contact name.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of angina, occlusion, thrombosis and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) and absorb gt1 ifu are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, a conclusive cause for the reported reabsorption issue, 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 manufacture, design or labeling.

• 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
• MDR Report Key: 8586875
• MDR Text Key: 144291909
• Report Number: 2024168-2019-03587
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• PMA/PMN Number: P150023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRAGONFLY OCT (OPTICAL COHERENCE TOMOGRAPHY); DRAGONFLY OCT (OPTICAL COHERENCE TOMOGRAPHY)
• Patient Outcome(s): Hospitalization; Required Intervention